ID

19745

Description

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

Mots-clés

Versions (4)
  1. 25/01/2017 25/01/2017 -
  2. 27/01/2017 27/01/2017 - Julian Varghese
  3. 30/01/2017 30/01/2017 -
  4. 08/02/2017 08/02/2017 -
Téléchargé le

25 janvier 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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Visit 2 GSK-AVA100468 NCT00381238

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Visit 2 GSK-AVA100468 NCT00381238

1 Formulaires  
formality
Description

formality

Protocol Identifier: AVA100468
Description

Protocol Identifier

Type de données

boolean

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Description

Subject Identifier

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Type de données

date

Alias
UMLS CUI [1]
C1320303
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure measurement
Description

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

Type de données

text

Unités de mesure
  • mm/Hg
Alias
UMLS CUI [1]
C0005823
mm/Hg
Heart rate
Description

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

Type de données

integer

Unités de mesure
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Central Laboratory (Non fasting samples)
Description

Central Laboratory (Non fasting samples)

Alias
UMLS CUI-1
C0022885
Central Laboratory (Non fasting samples)
Description

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

Type de données

text

Alias
UMLS CUI [1]
C0022885
Date samples taken
Description

Date samples taken

Type de données

date

Alias
UMLS CUI [1]
C1302413
Adverse events
Description

Adverse events

Alias
UMLS CUI-1
C0877248
Adverse events
Description

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.

Type de données

text

Alias
UMLS CUI [1]
C0877248
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Physical Examination
Description

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.

Type de données

text

Alias
UMLS CUI [1]
C0031809
Pedal Oedema
Description

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Pedal Oedema size
Description

Note: worst affected ankle

Type de données

integer

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

Note: worst affected ankle

Type de données

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0441987
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Similar models

Visit 2 GSK-AVA100468 NCT00381238

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Blood pressure
Item
Blood pressure measurement
text
C0005823 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Central Laboratory (Non fasting samples)
C0022885 (UMLS CUI-1)
Central Laboratory (Non fasting samples)
Item
Central Laboratory (Non fasting samples)
text
C0022885 (UMLS CUI [1])
Date samples taken
Item
Date samples taken
date
C1302413 (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
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
Code List
Pedal Oedema side
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Retour au début de la page 

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