ID

17700

Beschreibung

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.

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  1. 18.09.16 18.09.16 -
  2. 28.09.16 28.09.16 -
  3. 05.12.16 05.12.16 -
Hochgeladen am

28. September 2016

DOI

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

Englisch

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

1 Formulare  
General Information
Beschreibung

General Information

Protocol Identifier: AVA100193
Beschreibung

Protocol Identifier

Datentyp

boolean

Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Visit Date
Beschreibung

Visit Date

Datentyp

date

Visit Description: Visit 6
Beschreibung

Visit Description

Datentyp

boolean

Subject Continuation (See Description)
Beschreibung

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.

Datentyp

boolean

Vital Signs
Beschreibung

Vital Signs

Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
kg
Blood pressure (See Description): Systolic
Beschreibung

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

Datentyp

integer

Blood pressure: Diastolic
Beschreibung

Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
bpm
Central Laboratory (Non fasting samples)
Beschreibung

Central Laboratory (Non fasting samples)

Date samples taken
Beschreibung

Date samples taken

Datentyp

date

Concomitant Medications
Beschreibung

Concomitant Medications

Concomitant Medications
Beschreibung

Concomitant Medications

Datentyp

text

Adverse Events
Beschreibung

Adverse Events

Adverse Events
Beschreibung

Adverse Events

Datentyp

text

Physical Examination
Beschreibung

Physical Examination

Results from Physical Examination
Beschreibung

Results from Physical Examination

Datentyp

text

Pedal Oedema
Beschreibung

Pedal Oedema

Estimated Depth of Indentation
Beschreibung

Estimated Depth of Indentation

Datentyp

text

Indicate which ankle was assessed at this visit
Beschreibung

Ankle

Datentyp

text

Monitor Data Validation Checks
Beschreibung

Monitor Data Validation Checks

Monitor Data Validation Check completed
Beschreibung

Monitor Data Validation Check

Datentyp

boolean

Investigational Product
Beschreibung

Investigational Product

Investigational Product
Beschreibung

Investigational Product

Datentyp

text

Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

Stop Date

Datentyp

date

IP Container No.
Beschreibung

IP Container No.

Datentyp

integer

Total Number of Tablets Dispensed
Beschreibung

Total Number of Tablets Dispensed

Datentyp

float

Total Number of Tablets Returned
Beschreibung

Total Number of Tablets Returned

Datentyp

float

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

Discontinuation

Datentyp

boolean

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

End of Visit Reminder

Visit 7 scheduled
Beschreibung

Visit 7 scheduled

Datentyp

boolean

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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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