ID

24139

Description

Study ID: 100468 Clinical Study ID: AVA100468 Study Title: 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 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Early Withdrawal Follow-Up

Mots-clés

Versions (1)
  1. 25/07/2017 25/07/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

25 juillet 2017

DOI

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Licence

Creative Commons BY-NC-ND 3.0
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Early Withdrawal Follow-Up GSK Rosiglitazone Alzheimer's disease 100468

Anglais

Early Withdrawal Follow-Up GSK Rosiglitazone Alzheimer's disease 100468

1 Formulaires  
Central Laboratory Instructions (Non fasting samples)
Description

Central Laboratory Instructions (Non fasting samples)

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C1442085
Blood samples to be taken for laboratory assessment only where follow-up of abnormal value(s) is indicated.
Description

Central Laboratory Instructions

Type de données

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C1442085
Visit Information
Description

Visit Information

Alias
UMLS CUI-1
C0545082
Subject Identifier
Description

Subject Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Type de données

date

Unités de mesure
  • dd-mmm-yyyy
dd-mmm-yyyy
Investigator Instructions
Description

Investigator Instructions

Alias
UMLS CUI-1
C1442085
Make a Withdrawal call to the IVRS system.
Description

Investigator Instructions

Type de données

text

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: Systolic
Description

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

Type de données

float

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure: Diastolic
Description

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

Type de données

float

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
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

float

Unités de mesure
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
Central Laboratory (Non Fasting Samples)
Description

Central Laboratory (Non Fasting Samples)

Alias
UMLS CUI-1
C1880016
Date samples taken
Description

Collection Date

Type de données

text

Unités de mesure
  • dd-mmm-yy
Alias
UMLS CUI [1]
C1317250
dd-mmm-yy
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.
Description

Concomitant Medication

Type de données

text

Alias
UMLS CUI [1]
C2347852
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
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.
Description

Adverse Event

Type de données

text

Alias
UMLS CUI [1]
C0877248
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Perform a physical examination on the subject, including auscultation of heart and lungs. Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the Non-Serious Adverse Events page.
Description

Physical Examination

Type de données

text

Alias
UMLS CUI [1]
C0031809
Pedal Oedema
Description

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle thoughout the study. Tick one:
Description

Pedal Oedema: depth

Type de données

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0205125
Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle thoughout the study. Tick the appropriate box below to indicate which ankle was assessed at this visit:
Description

Pedal Oedema: Site

Type de données

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C1515974
End of Study Assessment
Description

End of Study Assessment

Alias
UMLS CUI-1
C0444496
Ensure the following sections are fully completed at this time: - Concomitant Medication - Non-serious Adverse Events - Study Conclusion
Description

End of Study Assessment

Type de données

text

Alias
UMLS CUI [1]
C0444496
Retour au début de la page

Similar models

Early Withdrawal Follow-Up GSK Rosiglitazone Alzheimer's disease 100468

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Central Laboratory Instructions (Non fasting samples)
C1880016 (UMLS CUI-1)
C1442085 (UMLS CUI-2)
Central Laboratory Instructions
Item
Blood samples to be taken for laboratory assessment only where follow-up of abnormal value(s) is indicated.
text
C1880016 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Item Group
Visit Information
C0545082 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
Item Group
Investigator Instructions
C1442085 (UMLS CUI-1)
Investigator Instructions
Item
Make a Withdrawal call to the IVRS system.
text
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Blood Pressure: Systolic
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Blood Pressure: Diastolic
float
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
float
C0018810 (UMLS CUI [1])
Item Group
Central Laboratory (Non Fasting Samples)
C1880016 (UMLS CUI-1)
Collection Date
Item
Date samples taken
text
C1317250 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.
text
C2347852 (UMLS CUI [1])
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Adverse Event
Item
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.
text
C0877248 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination
Item
Perform a physical examination on the subject, including auscultation of heart and lungs. Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the Non-Serious Adverse Events page.
text
C0031809 (UMLS CUI [1])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Item
Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle thoughout the study. Tick one:
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Pedal Oedema: depth
Code List
Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle thoughout the study. Tick one:
CL Item
<1 mm (0)
CL Item
1 - 2 mm (1)
CL Item
3 - 5 mm (2)
CL Item
6 - 10 mm (3)
CL Item
>10 mm (4)
Item
Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle thoughout the study. Tick the appropriate box below to indicate which ankle was assessed at this visit:
integer
C0574002 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Pedal Oedema: Site
Code List
Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle thoughout the study. Tick the appropriate box below to indicate which ankle was assessed at this visit:
CL Item
Left Ankle (1)
CL Item
Right Ankle (2)
Item Group
End of Study Assessment
C0444496 (UMLS CUI-1)
End of Study Assessment
Item
Ensure the following sections are fully completed at this time: - Concomitant Medication - Non-serious Adverse Events - Study Conclusion
text
C0444496 (UMLS CUI [1])
Retour au début de la page 

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