ID

19241

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 4/Visit 4.

Keywords

Versions (3)
  1. 9/16/16 9/16/16 -
  2. 10/2/16 10/2/16 -
  3. 12/14/16 12/14/16 -
Uploaded on

December 14, 2016

DOI

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License

Creative Commons BY-NC 3.0
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M.Alzheimer GSK - Book 4 NCT00334568/ GSK-AVA100193

English

M.Alzheimer GSK - Book 4NCT00334568/ GSK-AVA100193

1 forms  
General information
Description

General information

Alias
UMLS CUI-1
C1508263
Protocol Identifier: AVA100193
Description

Protocol Identifier

Data type

boolean

Alias
UMLS CUI [1]
C2826693
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 4
Description

Visit Description

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
Subject Continuation (See Description)
Description

If the subject is not continuing 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.

Data type

boolean

Alias
UMLS CUI [1]
C0805733
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Weight
Description

Weight

Data type

integer

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
Central Laboratory (Non Fasting Samples)
Description

Central Laboratory (Non Fasting Samples)

Alias
UMLS CUI-1
C1880016
Date samples taken
Description

Date samples taken

Data type

date

Alias
UMLS CUI [1]
C1302413
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
Depth of Indentation
Description

Depth of Indentation

Data type

text

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

Ankle

Data type

text

Alias
UMLS CUI [1]
C0003086
Monitor Data Validation Checks
Description

Monitor Data Validation Checks

Alias
UMLS CUI-1
C1519941
UMLS CUI-2
C0030695
Results from Monitor Data Validation Checks
Description

Monitor Data Validation Checks

Data type

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C0030695
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
Next Visit Scheduled
Description

Next Visit Scheduled

Data type

boolean

Alias
UMLS CUI [1]
C0515681
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Similar models

M.Alzheimer GSK - Book 4NCT00334568/ GSK-AVA100193

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General information
C1508263 (UMLS CUI-1)
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
C2826693 (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 4
boolean
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Subject Continuation
Item
Subject Continuation (See Description)
boolean
C0805733 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
integer
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
Central Laboratory (Non Fasting Samples)
C1880016 (UMLS CUI-1)
Date samples taken
Item
Date samples taken
date
C1302413 (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
Depth of Indentation
text
C2081478 (UMLS CUI [1])
Depth of Indentation
Code List
Depth of Indentation
CL Item
< 1 mm (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
Indication which ankle was assessed at this visit
text
C0003086 (UMLS CUI [1])
Indication which ankle was assessed at this visit
Code List
Indication which ankle was assessed at this visit
CL Item
Right ankle (1)
CL Item
Left ankle (2)
Item Group
Monitor Data Validation Checks
C1519941 (UMLS CUI-1)
C0030695 (UMLS CUI-2)
Monitor Data Validation Checks
Item
Results from Monitor Data Validation Checks
text
C1519941 (UMLS CUI [1,1])
C0030695 (UMLS CUI [1,2])
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)
Next Visit Scheduled
Item
Next Visit Scheduled
boolean
C0515681 (UMLS CUI [1])
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