ID

24139

Descripción

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

Palabras clave

Versiones (1)
  1. 25/7/17 25/7/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

25 de julio de 2017

DOI

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Licencia

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

Inglés

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

1 formularios  
Central Laboratory Instructions (Non fasting samples)
Descripción

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.
Descripción

Central Laboratory Instructions

Tipo de datos

text

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

Visit Information

Alias
UMLS CUI-1
C0545082
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

Unidades de medida
  • dd-mmm-yyyy
dd-mmm-yyyy
Investigator Instructions
Descripción

Investigator Instructions

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

Investigator Instructions

Tipo de datos

text

Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood Pressure: Systolic
Descripción

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

Tipo de datos

float

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure: Diastolic
Descripción

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

Tipo de datos

float

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

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

Tipo de datos

float

Unidades de medida
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
Central Laboratory (Non Fasting Samples)
Descripción

Central Laboratory (Non Fasting Samples)

Alias
UMLS CUI-1
C1880016
Date samples taken
Descripción

Collection Date

Tipo de datos

text

Unidades de medida
  • dd-mmm-yy
Alias
UMLS CUI [1]
C1317250
dd-mmm-yy
Concomitant Medication
Descripción

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.
Descripción

Concomitant Medication

Tipo de datos

text

Alias
UMLS CUI [1]
C2347852
Adverse Event
Descripción

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.
Descripción

Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Physical Examination
Descripción

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.
Descripción

Physical Examination

Tipo de datos

text

Alias
UMLS CUI [1]
C0031809
Pedal Oedema
Descripción

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:
Descripción

Pedal Oedema: depth

Tipo de datos

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:
Descripción

Pedal Oedema: Site

Tipo de datos

integer

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

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
Descripción

End of Study Assessment

Tipo de datos

text

Alias
UMLS CUI [1]
C0444496
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Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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