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) - (See Description)
Beschrijving

Central Laboratory Instructions (Fasting Samples) - (See Description)

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 (See Description)
Beschrijving

Subject Continuation (See Description)

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
mmHg
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
bpm
Concomitant Medications (See Description)
Beschrijving

Concomitant Medications (See Description)

Adverse Events (See Description)
Beschrijving

Adverse Events (See Description)

Physical Examination (See Description)
Beschrijving

Physical Examination (See Description)

Pedal Oedema (See Description)
Beschrijving

Pedal Oedema (See Description)

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 (See Description)
Beschrijving

Rating scale instructions (See Description)

Monitor Data Validation Checks (See Description)
Beschrijving

Monitor Data Validation Checks (See Description)

Investigational Product (See Description)
Beschrijving

Investigational Product (See Description)

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 (See Description)
Beschrijving

End of visit reminder (See Description)

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) - (See Description)
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 (See Description)
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
Heart rate
Item
Heart rate
integer
Item Group
Concomitant Medications (See Description)
Item Group
Adverse Events (See Description)
Item Group
Physical Examination (See Description)
Item Group
Pedal Oedema (See Description)
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 (See Description)
Item Group
Monitor Data Validation Checks (See Description)
Item Group
Investigational Product (See Description)
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 (See Description)