ID

19914

Beschrijving

An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Medicine: rosiglitazone, Condition: Alzheimer's Disease, Phase: 2, Clinical Study ID: AVA100468, Sponsor: GSK

Trefwoorden

Versies (2)
  1. 30-01-17 30-01-17 -
  2. 08-02-17 08-02-17 -
Geüploaded op

30 januari 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Visit 6 GSK-AVA100468 NCT00381238

Engels

Visit 6 GSK-AVA100468 NCT00381238

1 Formulieren  
formality
Beschrijving

formality

Protocol Identifier: AVA100468
Beschrijving

Protocol Identifier

Datatype

boolean

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic Blood pressure measurement
Beschrijving

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

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure measurement
Beschrijving

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

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschrijving

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

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Neurological Examination
Beschrijving

Neurological Examination

Alias
UMLS CUI-1
C0027853
Neurological Examination
Beschrijving

Perform a Neurological examination on the subject, including assessment of gait, balance, coordination, cranial nerves and motor and sensory systems. If any abnormalities are found as a result of the physical examination, these most be recorded on the Non-erious Adverse Events page.

Datatype

text

Alias
UMLS CUI [1]
C0027853
Central Laboratory (Non fasting samples)
Beschrijving

Central Laboratory (Non fasting samples)

Alias
UMLS CUI-1
C1880016
Central Laboratory (Non fasting samples)
Beschrijving

Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.

Datatype

text

Alias
UMLS CUI [1]
C1880016
Pregnancy Test
Beschrijving

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Pregnancy Test
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1]
C0032976
12-Lead ECG
Beschrijving

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Beschrijving

Date of ECG

Datatype

date

Alias
UMLS CUI [1]
C2826640
ECG result
Beschrijving

Complete an Adverse Event (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.

Datatype

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0456984
Concomitant medications
Beschrijving

Concomitant medications

Alias
UMLS CUI-1
C2347852
Concomitant Medications
Beschrijving

Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.

Datatype

text

Alias
UMLS CUI [1]
C2347852
Adverse Events
Beschrijving

Adverse Events

Alias
UMLS CUI-1
C0877248
Adverse events
Beschrijving

Record details of any new non-serious adverse events / serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events / Serious Adverse Events section.

Datatype

text

Alias
UMLS CUI [1]
C0877248
Physical Examination
Beschrijving

Physical Examination

Alias
UMLS CUI-1
C0031809
Physical Examination
Beschrijving

Perform a physical examination on the subject, including auscultation of heart and lungs. If any abnormalties are found as a result of the physical examination, these must be recorded on the Non-Serious Adverse Events page.

Datatype

text

Alias
UMLS CUI [1]
C0031809
Pedal Oedema
Beschrijving

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Pedal Oedema size
Beschrijving

Pedal Oedema size

Datatype

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0456389
Pedal Oedema side
Beschrijving

Pedal Oedema side

Datatype

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0441987
Rating Scale Instructions
Beschrijving

Rating Scale Instructions

Alias
UMLS CUI-1
C0681889
Rating Scale Instructions completed
Beschrijving

The following scales should be completed at this visit: ADAS-cog CIBIC+ NPI DAD

Datatype

boolean

Alias
UMLS CUI [1]
C0681889
Investigational Product
Beschrijving

Investigational Product

Alias
UMLS CUI-1
C0304229
Start Date
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschrijving

Stop Date

Datatype

date

Alias
UMLS CUI [1]
C0806020
Dose
Beschrijving

Dose

Datatype

text

Maateenheden
  • mg
Alias
UMLS CUI [1]
C3174092
mg
IP Container No
Beschrijving

IP Container No

Datatype

text

Alias
UMLS CUI [1]
C0180098
Compliance
Beschrijving

Compliance

Alias
UMLS CUI-1
C1321605
Total number of Tablets Dispensed
Beschrijving

Total number of Tablets Dispensed

Datatype

text

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Total number of Tablets Returned
Beschrijving

Total number of Tablets Returned

Datatype

text

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

Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0013227
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Visit 6 GSK-AVA100468 NCT00381238

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
formality
Protocol Identifier
Item
Protocol Identifier: AVA100468
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])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood pressure
Item
Systolic Blood pressure measurement
text
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure measurement
text
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Neurological Examination
C0027853 (UMLS CUI-1)
Neurological Examination
Item
Neurological Examination
text
C0027853 (UMLS CUI [1])
Item Group
Central Laboratory (Non fasting samples)
C1880016 (UMLS CUI-1)
Central Laboratory (Non fasting samples)
Item
Central Laboratory (Non fasting samples)
text
C1880016 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Pregnancy Test
Item
Pregnancy Test
text
C0032976 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
ECG result
integer
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
ECG result
Code List
ECG result
CL Item
Normal (1)
CL Item
Abnormal, not clinically significant (2)
CL Item
Abnormal, clinically significant (3)
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
Physical Examination
text
C0031809 (UMLS CUI [1])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Item
Pedal Oedema size
integer
C0574002 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Pedal Oedema size
Code List
Pedal Oedema size
CL Item
<1mm (1)
CL Item
1-2mm (2)
CL Item
3-5mm (3)
CL Item
6-10mm (4)
CL Item
>10mm (5)
Item
Pedal Oedema side
integer
C0574002 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Pedal Oedema side
Code List
Pedal Oedema side
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
C0304229 (UMLS CUI-1)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
IP Container No
Item
IP Container No
text
C0180098 (UMLS CUI [1])
Item Group
Compliance
C1321605 (UMLS CUI-1)
Total number of Tablets Dispensed
Item
Total number of Tablets Dispensed
text
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Total number of Tablets Returned
Item
Total number of Tablets Returned
text
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Compliance
Item
Has the subject missed investigational product for >7 consecutive days?
boolean
C1321605 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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