ID

17700

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 6/Visit 6.

Trefwoorden

Versies (3)
  1. 18-09-16 18-09-16 -
  2. 28-09-16 28-09-16 -
  3. 05-12-16 05-12-16 -
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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 6

Engels

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 6

1 Formulieren  
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: Visit 6
Beschrijving

Visit Description

Datatype

boolean

Subject Continuation (See Description)
Beschrijving

If the subject is not continuing in 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.

Datatype

boolean

Vital Signs
Beschrijving

Vital Signs

Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
kg
Blood pressure (See Description): 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
Alias
UMLS CUI [1]
C0005823
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

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

Monitor Data Validation Checks
Beschrijving

Monitor Data Validation Checks

Monitor Data Validation Check completed
Beschrijving

Monitor Data Validation Check

Datatype

boolean

Investigational Product
Beschrijving

Investigational Product

Investigational Product
Beschrijving

Investigational Product

Datatype

text

Start Date
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1]
C0808070
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 7 scheduled
Beschrijving

Visit 7 scheduled

Datatype

boolean

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Similar models

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 6

1 Formulieren
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: Visit 6
boolean
Subject Continuation (See Description)
Item
Subject Continuation (See Description)
boolean
Item Group
Vital Signs
Weight
Item
Weight
float
Blood pressure (See Description)
Item
Blood pressure (See Description): Systolic
integer
Blood pressure
Item
Blood pressure: Diastolic
integer
C0005823 (UMLS CUI [1])
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
Estimated Depth of Indentation
text
Estimated Depth of Indentation
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
Ankle
Code List
Indicate which ankle was assessed at this visit
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Item Group
Monitor Data Validation Checks
Monitor Data Validation Check
Item
Monitor Data Validation Check completed
boolean
Item Group
Investigational Product
Investigational Product
Item
Investigational Product
text
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
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 7 scheduled
Item
Visit 7 scheduled
boolean
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