ID

19117

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 8/Visit 8.

Stichworte

Versionen (2)
  1. 28.09.16 28.09.16 -
  2. 05.12.16 05.12.16 -
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5. Dezember 2016

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M.Alzheimer GSK - Book 8 NCT00334568/ GSK-AVA100193

Englisch

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 8

1 Formulare  
General Information
Beschreibung

General Information

Alias
UMLS CUI-1
C1508263
Protocol Identifier: AVA100193
Beschreibung

Protocol Identifier

Datentyp

boolean

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Visit Description: Visit 8
Beschreibung

Visit Description

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0678257
Instructions
Beschreibung

Instructions

Alias
UMLS CUI-1
C1442085
Instructions completed
Beschreibung

Instructions completed

Datentyp

boolean

Alias
UMLS CUI [1]
C1442085
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0518766
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure: systolic
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C0871470
Blood pressure: diastolic
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Neurological Exam
Beschreibung

Neurological Exam

Alias
UMLS CUI-1
C0027853
Results of Neurological Exam
Beschreibung

Neurological Examination

Datentyp

text

Alias
UMLS CUI [1]
C0027853
Central Laboratory (Fasting samples)
Beschreibung

Central Laboratory (Fasting samples)

Alias
UMLS CUI-1
C1880016
Date samples taken
Beschreibung

Date samples taken

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Pregnancy Test
Beschreibung

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Result of pregnancy test
Beschreibung

Pregnancy test result

Datentyp

text

Alias
UMLS CUI [1]
C0427777
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research
Beschreibung

Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research

Alias
UMLS CUI-1
C0031325
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research completed
Beschreibung

Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research completed

Datentyp

boolean

Alias
UMLS CUI [1]
C0031325
PGm-Transcriptomic Research
Beschreibung

PGm-Transcriptomic Research

Alias
UMLS CUI-1
C1831759
Has a blood sample been collected for PGm-Transcriptomic research?
Beschreibung

Blood sample collection

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
If yes, record date and time sample taken
Beschreibung

Date sample taken

Datentyp

datetime

Alias
UMLS CUI [1]
C1302413
PGm-Proteomic Research
Beschreibung

PGm-Proteomic Research

Alias
UMLS CUI-1
C1831759
Has a blood sample been collected for PGm-Proteomic research?
Beschreibung

Blood sample collection

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
If yes, record date and time sample taken
Beschreibung

Date and time

Datentyp

datetime

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2]
C0040223
Volume of one aliquot
Beschreibung

Volume

Datentyp

float

Maßeinheiten
  • ml
Alias
UMLS CUI [1]
C2700258
ml
Length of time the centrifuge ran
Beschreibung

Centrifuge time

Datentyp

integer

Maßeinheiten
  • minutes
Alias
UMLS CUI [1,1]
C0179834
UMLS CUI [1,2]
C0040223
minutes
Temperature of the centrifuge
Beschreibung

Temperature of the centrifuge

Datentyp

text

Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0179834
Centrifugation speed
Beschreibung

Centrifugation speed

Datentyp

integer

Maßeinheiten
  • r.p.m
Alias
UMLS CUI [1,1]
C0678536
UMLS CUI [1,2]
C0179834
r.p.m
Centrifugation rotor radius
Beschreibung

Centrifugation rotor radius

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0179834
UMLS CUI [1,2]
C1279083
cm
Time aliquotted samples were placed in the freezer
Beschreibung

Time in freezer

Datentyp

time

Alias
UMLS CUI [1,1]
C0175738
UMLS CUI [1,2]
C0040223
Temperature of freezer
Beschreibung

Temperature of freezer

Datentyp

integer

Maßeinheiten
  • -°C
Alias
UMLS CUI [1]
C2957069
-°C
12-Lead ECG
Beschreibung

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of the ECG
Beschreibung

Date of ECG

Datentyp

date

Alias
UMLS CUI [1]
C2826640
Result of the ECG
Beschreibung

ECG finding

Datentyp

text

Alias
UMLS CUI [1]
C0438154
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Concomitant Medications recorded -if applicable-
Beschreibung

Concomitant Medications

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Adverse Events
Beschreibung

Adverse Events

Alias
UMLS CUI-1
C0877248
Adverse Events
Beschreibung

Adverse Events

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
Results of physical examination
Beschreibung

Physical examination

Datentyp

text

Alias
UMLS CUI [1]
C0031809
Pedal Oedema
Beschreibung

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Depth of Indentation
Beschreibung

Depth of Indentation

Datentyp

text

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

Ankle

Datentyp

text

Alias
UMLS CUI [1]
C0003086
Rating Scale Instructions
Beschreibung

Rating Scale Instructions

Alias
UMLS CUI-1
C0681889
Rating Scale Instructions completed
Beschreibung

Rating Scale Instructions

Datentyp

boolean

Alias
UMLS CUI [1]
C0681889
Investigational Product Compliance
Beschreibung

Investigational Product Compliance

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Has the subject missed taking investigational product for > 7 consecutive days?
Beschreibung

Discontinuation

Datentyp

boolean

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

End of visit reminder

Alias
UMLS CUI-1
C1709896
UMLS CUI-2
C1320303
All required sections completed?
Beschreibung

Completion

Datentyp

boolean

Alias
UMLS CUI [1]
C0805732
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Ähnliche Modelle

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 8

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 8
boolean
C0545082 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
Instructions
C1442085 (UMLS CUI-1)
Instructions completed
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 Blood Pressure
Item
Blood pressure: diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Neurological Exam
C0027853 (UMLS CUI-1)
Neurological Examination
Item
Results of Neurological Exam
text
C0027853 (UMLS CUI [1])
Item Group
Central Laboratory (Fasting samples)
C1880016 (UMLS CUI-1)
Date samples taken
Item
Date samples taken
date
C1302413 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Item
Result of pregnancy test
text
C0427777 (UMLS CUI [1])
Result of pregnancy test
Code List
Result of pregnancy test
CL Item
Pregnant (1)
CL Item
Not pregnant (2)
Item Group
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research
C0031325 (UMLS CUI-1)
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research completed
Item
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research completed
boolean
C0031325 (UMLS CUI [1])
Item Group
PGm-Transcriptomic Research
C1831759 (UMLS CUI-1)
Blood sample collection
Item
Has a blood sample been collected for PGm-Transcriptomic research?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
If yes, record date and time sample taken
datetime
C1302413 (UMLS CUI [1])
Item Group
PGm-Proteomic Research
C1831759 (UMLS CUI-1)
Blood sample collection
Item
Has a blood sample been collected for PGm-Proteomic research?
boolean
C0005834 (UMLS CUI [1])
Date and time
Item
If yes, record date and time sample taken
datetime
C1302413 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
Volume
Item
Volume of one aliquot
float
C2700258 (UMLS CUI [1])
Centrifuge time
Item
Length of time the centrifuge ran
integer
C0179834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Temperature of the centrifuge
text
C0039476 (UMLS CUI [1,1])
C0179834 (UMLS CUI [1,2])
Temperature of the centrifuge
Code List
Temperature of the centrifuge
CL Item
Room temperature (1)
CL Item
Refrigerated centrifuge (2)
Centrifugation speed
Item
Centrifugation speed
integer
C0678536 (UMLS CUI [1,1])
C0179834 (UMLS CUI [1,2])
Centrifugation rotor radius
Item
Centrifugation rotor radius
integer
C0179834 (UMLS CUI [1,1])
C1279083 (UMLS CUI [1,2])
Time in freezer
Item
Time aliquotted samples were placed in the freezer
time
C0175738 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Temperature of freezer
Item
Temperature of freezer
integer
C2957069 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Date of ECG
Item
Date of the ECG
date
C2826640 (UMLS CUI [1])
Item
Result of the ECG
text
C0438154 (UMLS CUI [1])
Result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (-> complete an Adverse Event or Serious Adverse Event page) (3)
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Medications
Item
Concomitant Medications recorded -if applicable-
boolean
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 of 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
Rating Scale Instructions
C0681889 (UMLS CUI-1)
Rating Scale Instructions
Item
Rating Scale Instructions completed
boolean
C0681889 (UMLS CUI [1])
Item Group
Investigational Product Compliance
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Discontinuation
Item
Has the subject missed taking 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)
Completion
Item
All required sections completed?
boolean
C0805732 (UMLS CUI [1])
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