ID

17703

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 Book 5/Visit 5.

Trefwoorden

  1. 16-09-16 16-09-16 -
  2. 28-09-16 28-09-16 -
  3. 05-12-16 05-12-16 -
Geüploaded op

28 september 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 5

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 5

General Information
Beschrijving

General Information

Protocol Identifier: AVA100193
Beschrijving

Protocol Identifier

Datatype

boolean

Central Laboratory Instructions (Fasting Samples)
Beschrijving

Central Laboratory Instructions (Fasting Samples)

Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Visit Date
Beschrijving

Visit Date

Datatype

date

Visit Description: Visit 5
Beschrijving

Visit Description

Datatype

boolean

Date samples taken
Beschrijving

Date

Datatype

date

Subject Continuation
Beschrijving

Subject Continuation

All assessments completed or early withdrawal scheduled
Beschrijving

All assessments completed or early withdrawal scheduled

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
Concomitant Medications
Beschrijving

Concomitant Medications

Concomitant Medications
Beschrijving

Concomitant Medications

Datatype

text

Adverse Events
Beschrijving

Adverse Events

Adverse Events
Beschrijving

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

Estimated Depth of Indentation
Beschrijving

Estimated Depth of Indentation

Datatype

text

Indicate which ankle was assessed at this visit
Beschrijving

Ankle

Datatype

text

Rating scale instructions
Beschrijving

Rating scale instructions

All requested scales completed
Beschrijving

Scales completed

Datatype

boolean

Monitor Data Validation Checks
Beschrijving

Monitor Data Validation Checks

Monitor Data Validation Check completed
Beschrijving

Monitor Data Validation Check completed

Datatype

boolean

Investigational Product
Beschrijving

Investigational Product

Investigational Product
Beschrijving

Investigational Product

Datatype

text

Start Date
Beschrijving

Start Date

Datatype

date

Stop Date
Beschrijving

Stop Date

Datatype

date

IP Container No.
Beschrijving

IP Container No.

Datatype

integer

Total Number of Tablets Dispensed
Beschrijving

Total Number of Tablets Dispensed

Datatype

float

Total Number of Tablets Returned
Beschrijving

Total Number of Tablets Returned

Datatype

float

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

Discontinuation

Datatype

boolean

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

End of visit reminder

Visit 6 scheduled
Beschrijving

Visit 6 scheduled

Datatype

boolean

Similar models

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 5

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General Information
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
Item Group
Central Laboratory Instructions (Fasting Samples)
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Visit Description
Item
Visit Description: Visit 5
boolean
Date
Item
Date samples taken
date
Item Group
Subject Continuation
All assessments completed or early withdrawal scheduled
Item
All assessments completed or early withdrawal scheduled
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
Estimated Depth of Indentation
text
Code List
Estimated Depth of Indentation
CL Item
< 1mm (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
Rating scale instructions
Scales completed
Item
All requested scales completed
boolean
Item Group
Monitor Data Validation Checks
Monitor Data Validation Check completed
Item
Monitor Data Validation Check completed
boolean
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
Visit 6 scheduled
Item
Visit 6 scheduled
boolean

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