ID

19171

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 the Early Withdrawal.

Keywords

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

December 9, 2016

DOI

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License

Creative Commons BY-NC 3.0
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M.Alzheimer GSK - Early Withdrawal NCT00334568/ GSK-AVA100193

English

M.Alzheimer GSK - Early Withdrawal NCT00334568/ 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: Early Withdrawal
Description

Visit Description

Data type

boolean

Instructions
Description

Instructions

Alias
UMLS CUI-1
C1442085
Instructions completed
Description

Instructions

Data type

boolean

Alias
UMLS CUI [1]
C1442085
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 BloodPressure

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
Pregnancy test: pregnant
Description

If subject is female and of childbearing potential a serum pregnancy test must be performed.

Data type

boolean

Alias
UMLS CUI [1]
C0032976
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
Non-Serious Adverse Events/Serious Adverse Events
Description

Non-Serious Adverse Events/Serious Adverse Events

Data type

text

Alias
UMLS CUI [1]
C1518404
UMLS CUI [2]
C1519255
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
Indicate which ankle was assessed at this visit
Description

Ankle

Data type

text

Alias
UMLS CUI [1]
C0003086
Further Instructions
Description

Further Instructions

Alias
UMLS CUI-1
C1517331
UMLS CUI-2
C1442085
Instructions followed and next visit scheduled?
Description

Instructions followed and visit scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C1517331
UMLS CUI [1,2]
C1442085
UMLS CUI [2]
C0515681
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Similar models

M.Alzheimer GSK - Early Withdrawal NCT00334568/ 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: Early Withdrawal
boolean
Item Group
Instructions
C1442085 (UMLS CUI-1)
Instructions
Item
Instructions completed
boolean
C1442085 (UMLS CUI [1])
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 BloodPressure
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])
Pregnancy test
Item
Pregnancy test: pregnant
boolean
C0032976 (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)
Non-Serious Adverse Events/Serious Adverse Events
Item
Non-Serious Adverse Events/Serious Adverse Events
text
C1518404 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
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
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
Further Instructions
C1517331 (UMLS CUI-1)
C1442085 (UMLS CUI-2)
Instructions followed and visit scheduled
Item
Instructions followed and next visit scheduled?
boolean
C1517331 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
C0515681 (UMLS CUI [2])
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