ID

19171

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 the Early Withdrawal.

Palabras clave

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

9 de diciembre de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

M.Alzheimer GSK - Early Withdrawal NCT00334568/ GSK-AVA100193

Inglés

M.Alzheimer GSK - Early Withdrawal NCT00334568/ GSK-AVA100193

1 formularios  
General Information
Descripción

General Information

Alias
UMLS CUI-1
C1508263
Protocol Identifier: AVA100193
Descripción

Protocol Identifier

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Visit Description: Early Withdrawal
Descripción

Visit Description

Tipo de datos

boolean

Instructions
Descripción

Instructions

Alias
UMLS CUI-1
C1442085
Instructions completed
Descripción

Instructions

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1442085
Vital signs
Descripción

Vital signs

Alias
UMLS CUI-1
C0518766
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
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

Alias
UMLS CUI [1]
C0871470
Blood pressure: diastolic
Descripción

Diastolic BloodPressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Central Laboratory (Non Fasting Samples)
Descripción

Central Laboratory (Non Fasting Samples)

Alias
UMLS CUI-1
C1880016
Date samples taken
Descripción

Date samples taken

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Pregnancy test: pregnant
Descripción

If subject is female and of childbearing potential a serum pregnancy test must be performed.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032976
Concomitant Medications
Descripción

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Concomitant Medications
Descripción

Concomitant Medications

Tipo de datos

text

Alias
UMLS CUI [1]
C2347852
Adverse Events
Descripción

Adverse Events

Alias
UMLS CUI-1
C0877248
Non-Serious Adverse Events/Serious Adverse Events
Descripción

Non-Serious Adverse Events/Serious Adverse Events

Tipo de datos

text

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2]
C1519255
Physical Examination
Descripción

Physical Examination

Alias
UMLS CUI-1
C0031809
Results from Physical Examination
Descripción

Physical Examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0031809
Pedal Oedema
Descripción

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Depth of Indentation
Descripción

Depth of Indentation

Tipo de datos

text

Alias
UMLS CUI [1]
C2081478
Indicate which ankle was assessed at this visit
Descripción

Ankle

Tipo de datos

text

Alias
UMLS CUI [1]
C0003086
Further Instructions
Descripción

Further Instructions

Alias
UMLS CUI-1
C1517331
UMLS CUI-2
C1442085
Instructions followed and next visit scheduled?
Descripción

Instructions followed and visit scheduled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1517331
UMLS CUI [1,2]
C1442085
UMLS CUI [2]
C0515681
Volver a la parte superior de la página

Similar models

M.Alzheimer GSK - Early Withdrawal NCT00334568/ GSK-AVA100193

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Visit Description
Item
Visit Description: Early Withdrawal
boolean
Item Group
Instructions
C1442085 (UMLS CUI-1)
Instructions
Item
Instructions completed
boolean
C1442085 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Blood pressure: systolic
integer
C0871470 (UMLS CUI [1])
Diastolic BloodPressure
Item
Blood pressure: diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Central Laboratory (Non Fasting Samples)
C1880016 (UMLS CUI-1)
Date samples taken
Item
Date samples taken
date
C1302413 (UMLS CUI [1])
Pregnancy test
Item
Pregnancy test: pregnant
boolean
C0032976 (UMLS CUI [1])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Medications
Item
Concomitant Medications
text
C2347852 (UMLS CUI [1])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Non-Serious Adverse Events/Serious Adverse Events
Item
Non-Serious Adverse Events/Serious Adverse Events
text
C1518404 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination
Item
Results from Physical Examination
text
C0031809 (UMLS CUI [1])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Item
Depth of Indentation
text
C2081478 (UMLS CUI [1])
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
C0003086 (UMLS CUI [1])
Ankle
Code List
Indicate which ankle was assessed at this visit
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Item Group
Further Instructions
C1517331 (UMLS CUI-1)
C1442085 (UMLS CUI-2)
Instructions followed and visit scheduled
Item
Instructions followed and next visit scheduled?
boolean
C1517331 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
C0515681 (UMLS CUI [2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial