ID

19117

Beskrivning

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.

Nyckelord

Versioner (2)
  1. 2016-09-28 2016-09-28 -
  2. 2016-12-05 2016-12-05 -
Uppladdad den

5 december 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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

Engelsk

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

1 Formulär  
General Information
Beskrivning

General Information

Alias
UMLS CUI-1
C1508263
Protocol Identifier: AVA100193
Beskrivning

Protocol Identifier

Datatyp

boolean

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

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

Visit Description

Datatyp

boolean

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

Instructions

Alias
UMLS CUI-1
C1442085
Instructions completed
Beskrivning

Instructions completed

Datatyp

boolean

Alias
UMLS CUI [1]
C1442085
Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure: systolic
Beskrivning

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

Datatyp

integer

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

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Neurological Exam
Beskrivning

Neurological Exam

Alias
UMLS CUI-1
C0027853
Results of Neurological Exam
Beskrivning

Neurological Examination

Datatyp

text

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

Central Laboratory (Fasting samples)

Alias
UMLS CUI-1
C1880016
Date samples taken
Beskrivning

Date samples taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Pregnancy Test
Beskrivning

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Result of pregnancy test
Beskrivning

Pregnancy test result

Datatyp

text

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

Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research

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

Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research completed

Datatyp

boolean

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

PGm-Transcriptomic Research

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

Blood sample collection

Datatyp

boolean

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

Date sample taken

Datatyp

datetime

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

PGm-Proteomic Research

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

Blood sample collection

Datatyp

boolean

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

Date and time

Datatyp

datetime

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

Volume

Datatyp

float

Måttenheter
  • ml
Alias
UMLS CUI [1]
C2700258
ml
Length of time the centrifuge ran
Beskrivning

Centrifuge time

Datatyp

integer

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

Temperature of the centrifuge

Datatyp

text

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

Centrifugation speed

Datatyp

integer

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

Centrifugation rotor radius

Datatyp

integer

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

Time in freezer

Datatyp

time

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

Temperature of freezer

Datatyp

integer

Måttenheter
  • -°C
Alias
UMLS CUI [1]
C2957069
-°C
12-Lead ECG
Beskrivning

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of the ECG
Beskrivning

Date of ECG

Datatyp

date

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

ECG finding

Datatyp

text

Alias
UMLS CUI [1]
C0438154
Concomitant Medications
Beskrivning

Concomitant Medications

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

Concomitant Medications

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Adverse Events
Beskrivning

Adverse Events

Alias
UMLS CUI-1
C0877248
Adverse Events
Beskrivning

Adverse Events

Datatyp

text

Alias
UMLS CUI [1]
C0877248
Physical Examination
Beskrivning

Physical Examination

Alias
UMLS CUI-1
C0031809
Results of physical examination
Beskrivning

Physical examination

Datatyp

text

Alias
UMLS CUI [1]
C0031809
Pedal Oedema
Beskrivning

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Depth of Indentation
Beskrivning

Depth of Indentation

Datatyp

text

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

Ankle

Datatyp

text

Alias
UMLS CUI [1]
C0003086
Rating Scale Instructions
Beskrivning

Rating Scale Instructions

Alias
UMLS CUI-1
C0681889
Rating Scale Instructions completed
Beskrivning

Rating Scale Instructions

Datatyp

boolean

Alias
UMLS CUI [1]
C0681889
Investigational Product Compliance
Beskrivning

Investigational Product Compliance

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

Discontinuation

Datatyp

boolean

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

End of visit reminder

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

Completion

Datatyp

boolean

Alias
UMLS CUI [1]
C0805732
Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial