ID

17700

Description

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.

Mots-clés

Versions (3)
  1. 18/09/2016 18/09/2016 -
  2. 28/09/2016 28/09/2016 -
  3. 05/12/2016 05/12/2016 -
Téléchargé le

28 septembre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 6

Anglais

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

1 Formulaires  
General Information
Description

General Information

Protocol Identifier: AVA100193
Description

Protocol Identifier

Type de données

boolean

Subject Identifier
Description

Subject Identifier

Type de données

integer

Visit Date
Description

Visit Date

Type de données

date

Visit Description: Visit 6
Description

Visit Description

Type de données

boolean

Subject Continuation (See Description)
Description

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.

Type de données

boolean

Vital Signs
Description

Vital Signs

Weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
kg
Blood pressure (See Description): Systolic
Description

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

Type de données

integer

Blood pressure: Diastolic
Description

Blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Description

Heart rate

Type de données

integer

Unités de mesure
  • bpm
bpm
Central Laboratory (Non fasting samples)
Description

Central Laboratory (Non fasting samples)

Date samples taken
Description

Date samples taken

Type de données

date

Concomitant Medications
Description

Concomitant Medications

Concomitant Medications
Description

Concomitant Medications

Type de données

text

Adverse Events
Description

Adverse Events

Adverse Events
Description

Adverse Events

Type de données

text

Physical Examination
Description

Physical Examination

Results from Physical Examination
Description

Results from Physical Examination

Type de données

text

Pedal Oedema
Description

Pedal Oedema

Estimated Depth of Indentation
Description

Estimated Depth of Indentation

Type de données

text

Indicate which ankle was assessed at this visit
Description

Ankle

Type de données

text

Monitor Data Validation Checks
Description

Monitor Data Validation Checks

Monitor Data Validation Check completed
Description

Monitor Data Validation Check

Type de données

boolean

Investigational Product
Description

Investigational Product

Investigational Product
Description

Investigational Product

Type de données

text

Start Date
Description

Start Date

Type de données

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Description

Stop Date

Type de données

date

IP Container No.
Description

IP Container No.

Type de données

integer

Total Number of Tablets Dispensed
Description

Total Number of Tablets Dispensed

Type de données

float

Total Number of Tablets Returned
Description

Total Number of Tablets Returned

Type de données

float

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

Discontinuation

Type de données

boolean

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

End of Visit Reminder

Visit 7 scheduled
Description

Visit 7 scheduled

Type de données

boolean

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Similar models

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

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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