ID

17700

Descrição

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.

Palavras-chave

  1. 18/09/2016 18/09/2016 -
  2. 28/09/2016 28/09/2016 -
  3. 05/12/2016 05/12/2016 -
Transferido a

28 de setembro de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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

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

General Information
Descrição

General Information

Protocol Identifier: AVA100193
Descrição

Protocol Identifier

Tipo de dados

boolean

Subject Identifier
Descrição

Subject Identifier

Tipo de dados

integer

Visit Date
Descrição

Visit Date

Tipo de dados

date

Visit Description: Visit 6
Descrição

Visit Description

Tipo de dados

boolean

Subject Continuation (See Description)
Descrição

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.

Tipo de dados

boolean

Vital Signs
Descrição

Vital Signs

Weight
Descrição

Weight

Tipo de dados

float

Unidades de medida
  • kg
kg
Blood pressure (See Description): Systolic
Descrição

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

Tipo de dados

integer

Blood pressure: Diastolic
Descrição

Blood pressure

Tipo de dados

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Descrição

Heart rate

Tipo de dados

integer

Unidades de medida
  • bpm
bpm
Central Laboratory (Non fasting samples)
Descrição

Central Laboratory (Non fasting samples)

Date samples taken
Descrição

Date samples taken

Tipo de dados

date

Concomitant Medications
Descrição

Concomitant Medications

Concomitant Medications
Descrição

Concomitant Medications

Tipo de dados

text

Adverse Events
Descrição

Adverse Events

Adverse Events
Descrição

Adverse Events

Tipo de dados

text

Physical Examination
Descrição

Physical Examination

Results from Physical Examination
Descrição

Results from Physical Examination

Tipo de dados

text

Pedal Oedema
Descrição

Pedal Oedema

Estimated Depth of Indentation
Descrição

Estimated Depth of Indentation

Tipo de dados

text

Indicate which ankle was assessed at this visit
Descrição

Ankle

Tipo de dados

text

Monitor Data Validation Checks
Descrição

Monitor Data Validation Checks

Monitor Data Validation Check completed
Descrição

Monitor Data Validation Check

Tipo de dados

boolean

Investigational Product
Descrição

Investigational Product

Investigational Product
Descrição

Investigational Product

Tipo de dados

text

Start Date
Descrição

Start Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Descrição

Stop Date

Tipo de dados

date

IP Container No.
Descrição

IP Container No.

Tipo de dados

integer

Total Number of Tablets Dispensed
Descrição

Total Number of Tablets Dispensed

Tipo de dados

float

Total Number of Tablets Returned
Descrição

Total Number of Tablets Returned

Tipo de dados

float

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

Discontinuation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0457454
End of Visit Reminder
Descrição

End of Visit Reminder

Visit 7 scheduled
Descrição

Visit 7 scheduled

Tipo de dados

boolean

Similar models

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

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
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
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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