ID

17761

Beschrijving

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.

Trefwoorden

  1. 03-10-16 03-10-16 -
  2. 09-12-16 09-12-16 -
Geüploaded op

3 oktober 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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

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

General Information
Beschrijving

General Information

Protocol Identifier: AVA100193
Beschrijving

Protocol Identifier

Datatype

boolean

Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Visit Date
Beschrijving

Visit Date

Datatype

date

Visit Description: Early Withdrawal
Beschrijving

Visit Description

Datatype

boolean

Instructions
Beschrijving

Instructions

Instructions completed
Beschrijving

Instructions completed

Datatype

boolean

Vital signs
Beschrijving

Vital signs

Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
kg
Blood pressure: systolic
Beschrijving

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

Datatype

integer

Blood pressure: diastolic
Beschrijving

Blood pressure

Datatype

integer

Maateenheden
  • mmHg
mmHg
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
bpm
Central Laboratory (Non Fasting Samples)
Beschrijving

Central Laboratory (Non Fasting Samples)

Date samples taken
Beschrijving

Date samples taken

Datatype

date

Pregnancy test: pregnant
Beschrijving

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

Datatype

boolean

Concomitant Medications
Beschrijving

Concomitant Medications

Concomitant Medications
Beschrijving

Concomitant Medications

Datatype

text

Adverse Events
Beschrijving

Adverse Events

Non-Serious Adverse Events/Serious Adverse Events
Beschrijving

Non-Serious Adverse Events/Serious Adverse Events

Datatype

text

Physical Examination
Beschrijving

Physical Examination

Results from Physical Examination
Beschrijving

Results from Physical Examination

Datatype

text

Pedal Oedema
Beschrijving

Pedal Oedema

Depth of Indentation
Beschrijving

Depth of Indentation

Datatype

text

Indicate which ankle was assessed at this visit
Beschrijving

Ankle

Datatype

text

Further Instructions
Beschrijving

Further Instructions

Instructions followed and next visit scheduled?
Beschrijving

Instructions followed and next visit scheduled?

Datatype

boolean

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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: Early Withdrawal
boolean
Item Group
Instructions
Instructions completed
Item
Instructions completed
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
Central Laboratory (Non Fasting Samples)
Date samples taken
Item
Date samples taken
date
Pregnancy test
Item
Pregnancy test: pregnant
boolean
Item Group
Concomitant Medications
Concomitant Medications
Item
Concomitant Medications
text
Item Group
Adverse Events
Non-Serious Adverse Events/Serious Adverse Events
Item
Non-Serious Adverse Events/Serious 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
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
Code List
Indicate which ankle was assessed at this visit
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Item Group
Further Instructions
Instructions followed and next visit scheduled?
Item
Instructions followed and next visit scheduled?
boolean

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