ID

19114

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 5/Visit 5.

Keywords

Versions (3)
  1. 9/16/16 9/16/16 -
  2. 9/28/16 9/28/16 -
  3. 12/5/16 12/5/16 -
Uploaded on

December 5, 2016

DOI

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License

Creative Commons BY-NC 3.0
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M.Alzheimer GSK - Book 5 NCT00334568/ GSK-AVA100193

English

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 5

1 forms  
General Information
Description

General Information

Alias
UMLS CUI-1
C1508263
Protocol Identifier: AVA100193
Description

Study Identifier

Data type

boolean

Alias
UMLS CUI [1]
C2826693
Central Laboratory Instructions (Fasting Samples)
Description

Central Laboratory Instructions (Fasting Samples)

Alias
UMLS CUI-1
C1880016
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit Description: Visit 5
Description

Visit Description

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
Date samples taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Subject Continuation
Description

Subject Continuation

Alias
UMLS CUI-1
C0805733
All assessments completed or early withdrawal scheduled
Description

Evaluation or withdrawal

Data type

boolean

Alias
UMLS CUI [1]
C0220825
UMLS CUI [2]
C2349954
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure: Systolic
Description

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

Data type

integer

Alias
UMLS CUI [1]
C0871470
Blood pressure: Diastolic
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Concomitant Medications
Description

Concomitant Medications

Data type

text

Alias
UMLS CUI [1]
C2347852
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Adverse Events
Description

Adverse Events

Data type

text

Alias
UMLS CUI [1]
C0877248
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Results from Physical Examination
Description

Physical Examination

Data type

text

Alias
UMLS CUI [1]
C0031809
Pedal Oedema
Description

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Estimated Depth of Indentation
Description

Depth of Indentation

Data type

text

Alias
UMLS CUI [1]
C2081478
Indicate which ankle was assessed at this visit
Description

Ankle

Data type

text

Alias
UMLS CUI [1]
C0003086
Rating scale instructions
Description

Rating scale instructions

Alias
UMLS CUI-1
C0681889
All requested scales completed
Description

Scales completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0205197
Monitor Data Validation Checks
Description

Monitor Data Validation Checks

Alias
UMLS CUI-1
C1519941
Monitor Data Validation Check completed
Description

Monitor Data Validation Check completed

Data type

boolean

Alias
UMLS CUI [1]
C1519941
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product
Description

Investigational Product

Data type

text

Alias
UMLS CUI [1]
C0304229
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
IP Container No.
Description

IP Container No.

Data type

integer

Alias
UMLS CUI [1]
C0180098
Total Number of Tablets Dispensed
Description

Total Number of Tablets Dispensed

Data type

float

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Total Number of Tablets Returned
Description

Total Number of Tablets Returned

Data type

float

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Has the subject missed investigational product for > 7 consecutive days?
Description

Discontinuation

Data type

boolean

Alias
UMLS CUI [1]
C0457454
End of visit reminder
Description

End of visit reminder

Alias
UMLS CUI-1
C1709896
UMLS CUI-2
C1320303
Visit 6 scheduled
Description

Visit scheduled

Data type

boolean

Alias
UMLS CUI [1]
C0515681
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Similar models

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 5

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
Study Identifier
Item
Protocol Identifier: AVA100193
boolean
C2826693 (UMLS CUI [1])
Item Group
Central Laboratory Instructions (Fasting Samples)
C1880016 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Visit Description
Item
Visit Description: Visit 5
boolean
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Date sample taken
Item
Date samples taken
date
C1302413 (UMLS CUI [1])
Item Group
Subject Continuation
C0805733 (UMLS CUI-1)
Evaluation or withdrawal
Item
All assessments completed or early withdrawal scheduled
boolean
C0220825 (UMLS CUI [1])
C2349954 (UMLS CUI [2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Blood pressure: Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Blood pressure: Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Medications
Item
Concomitant Medications
text
C2347852 (UMLS CUI [1])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Adverse Events
Item
Adverse Events
text
C0877248 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination
Item
Results from Physical Examination
text
C0031809 (UMLS CUI [1])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Item
Estimated Depth of Indentation
text
C2081478 (UMLS CUI [1])
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
C0003086 (UMLS CUI [1])
Ankle
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
C0681889 (UMLS CUI-1)
Scales completed
Item
All requested scales completed
boolean
C0681889 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item Group
Monitor Data Validation Checks
C1519941 (UMLS CUI-1)
Monitor Data Validation Check completed
Item
Monitor Data Validation Check completed
boolean
C1519941 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Investigational Product
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
IP Container No.
Item
IP Container No.
integer
C0180098 (UMLS CUI [1])
Total Number of Tablets Dispensed
Item
Total Number of Tablets Dispensed
float
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Total Number of Tablets Returned
Item
Total Number of Tablets Returned
float
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Discontinuation
Item
Has the subject missed investigational product for > 7 consecutive days?
boolean
C0457454 (UMLS CUI [1])
Item Group
End of visit reminder
C1709896 (UMLS CUI-1)
C1320303 (UMLS CUI-2)
Visit scheduled
Item
Visit 6 scheduled
boolean
C0515681 (UMLS CUI [1])
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