ID

24079

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 Visit 6

Keywords

  1. 7/25/17 7/25/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 25, 2017

DOI

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License

Creative Commons BY-NC-ND 3.0

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Visit 6 GSK Rosiglitazone Alzheimer's disease 100468

Visit 6 GSK Rosiglitazone Alzheimer's disease 100468

Central Laboratory Instructions
Description

Central Laboratory Instructions

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C1442085
Laboratory samples are to be collected when the subject is in the fasting state (No food or dirng [except water] for at least 8 hours prior to sampling). If the subject isnot in the fasted state, do not take samples. Schedule the subject to attend the clinic in the fasted state within the next 5 days for collection of laboratory samples.
Description

Central Laboratory Instructions

Data type

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

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Measurement units
  • dd-mmm-yyyy
dd-mmm-yyyy
Investigator Instructions
Description

Investigator Instructions

Alias
UMLS CUI-1
C1442085
Telephone the IVRS system to register the visit. (Note that if the subject is not continuing in the study, you should make a Withdrawal call rather than a Visit Registration call).
Description

Investigator Instructions

Data type

text

Subject Continuation
Description

Subject Continuation

Alias
UMLS CUI-1
C0805733
If the subject is not continuing in the stduy, complete all assessments for this visit, and also the Early Withdrawal ADAS-cog and CIBIC+ assessments in the Assessment Scale and CIBIC+ folders. The ADAS- cog and CIBIC+ results should then be recorded on the pages at the end of this visit. Ensure that all sections of the CRF (including the Study Conclusion page) are completed appropriately. Schedule an early withdrawal follow-up visit for 14 +/- 7 days after this visit. Make a Withdrawal call to the IVRS system.
Description

Subject Continuation

Data type

text

Alias
UMLS CUI [1]
C0805733
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Description

Weight

Data type

float

Measurement units
  • 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.

Data type

float

Measurement units
  • 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.

Data type

float

Measurement units
  • 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.

Data type

float

Measurement units
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
Neurological Examination
Description

Neurological Examination

Alias
UMLS CUI-1
C0027853
Perform a Neurological examination on the subject, including assessment of gait, balance, coordination, cranial nerves and motor and sensory systems. Note: If any abnormalities are found as a result of the physial examination, these must be recorded on the Non-Serious Adverse Events page.
Description

Neurological Examination

Data type

text

Alias
UMLS CUI [1]
C0027853
Central Laboratory (Fasting Samples)
Description

Central Laboratory (Fasting Samples)

Alias
UMLS CUI-1
C1880016
Date samples taken
Description

Collection Date

Data type

text

Measurement units
  • dd-mmm-yy
Alias
UMLS CUI [1]
C1317250
dd-mmm-yy
Pregnancy Test
Description

Pregnancy Test

Alias
UMLS CUI-1
C0032976
If subject is female and of childbearing potential a serum pregnancy test must be performed.
Description

Pregnancy Test

Data type

text

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

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Description

Date of ECG

Data type

date

Measurement units
  • dd-mmm-yy
Alias
UMLS CUI [1]
C2826640
dd-mmm-yy
Result of the ECG
Description

[3] abnormal - clinically significant: Complete an Adverse Event (AE) or Serious Adverse Event (SAE) ge(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.

Data type

integer

Alias
UMLS CUI [1]
C1623258
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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C1515974
The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD
Description

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

Alias
UMLS CUI-1
C0681889
ADAS-COG Summary
Description

ADAS-COG

Data type

text

Alias
UMLS CUI [1]
C3539026
CIBIC-Plus Summary
Description

CIBIC-Plus Summary

Data type

text

Alias
UMLS CUI [1,1]
C0443172
UMLS CUI [1,2]
C0449820
Neuropsychiatric Inventory (NPI) Definitions for frequency, severity and distress
Description

Neuropsychiatric Inventory (NPI)

Data type

text

Alias
UMLS CUI [1]
C3539727
Investigational Product/ Compliance - Dispense Weeks 25 - 32 study medication as specified by the IVRS system. Record start date, container number and number of tablets dispensed below (stop date and tablets returned will be completed when the bottle is returned).
Description

Investigational Product/ Compliance - Dispense Weeks 25 - 32 study medication as specified by the IVRS system. Record start date, container number and number of tablets dispensed below (stop date and tablets returned will be completed when the bottle is returned).

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Investigational Product (e.g Bottle 1)
Description

Investigational Product

Data type

text

Alias
UMLS CUI [1]
C0304229
Start Date
Description

Start Date

Data type

date

Measurement units
  • dd-mmm-yy
Alias
UMLS CUI [1]
C0808070
dd-mmm-yy
Stop Date
Description

Stop Date

Data type

date

Measurement units
  • dd-mmm-yy
Alias
UMLS CUI [1]
C0806020
dd-mmm-yy
Dose
Description

Dose

Data type

integer

Measurement units
  • mg
mg
IP Container No.
Description

IP Container Number

Data type

text

Alias
UMLS CUI [1]
C0180098
Total number of Tablets Dispensed
Description

Total number of Tablets Dispensed

Data type

float

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

Total number of Tablets Returned

Data type

float

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

Discontinuation

Data type

boolean

Alias
UMLS CUI [1]
C0457454
End of Visit Reminder
Description

End of Visit Reminder

Alias
UMLS CUI-1
C1709896
UMLS CUI-2
C1320303
Schedule Visit 7 for 8 weeks (+/- 3 days) after this visit. It is not necessary for the subject to be fasted.
Description

End of Visit Reminder

Data type

text

Alias
UMLS CUI [1,1]
C1709896
UMLS CUI [1,2]
C1320303

Similar models

Visit 6 GSK Rosiglitazone Alzheimer's disease 100468

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Central Laboratory Instructions
C1880016 (UMLS CUI-1)
C1442085 (UMLS CUI-2)
Central Laboratory Instructions
Item
Laboratory samples are to be collected when the subject is in the fasting state (No food or dirng [except water] for at least 8 hours prior to sampling). If the subject isnot in the fasted state, do not take samples. Schedule the subject to attend the clinic in the fasted state within the next 5 days for collection of laboratory samples.
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
Telephone the IVRS system to register the visit. (Note that if the subject is not continuing in the study, you should make a Withdrawal call rather than a Visit Registration call).
text
Item Group
Subject Continuation
C0805733 (UMLS CUI-1)
Subject Continuation
Item
If the subject is not continuing in the stduy, complete all assessments for this visit, and also the Early Withdrawal ADAS-cog and CIBIC+ assessments in the Assessment Scale and CIBIC+ folders. The ADAS- cog and CIBIC+ results should then be recorded on the pages at the end of this visit. Ensure that all sections of the CRF (including the Study Conclusion page) are completed appropriately. Schedule an early withdrawal follow-up visit for 14 +/- 7 days after this visit. Make a Withdrawal call to the IVRS system.
text
C0805733 (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
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
Neurological Examination
C0027853 (UMLS CUI-1)
Neurological Examination
Item
Perform a Neurological examination on the subject, including assessment of gait, balance, coordination, cranial nerves and motor and sensory systems. Note: If any abnormalities are found as a result of the physial examination, these must be recorded on the Non-Serious Adverse Events page.
text
C0027853 (UMLS CUI [1])
Item Group
Central Laboratory (Fasting Samples)
C1880016 (UMLS CUI-1)
Collection Date
Item
Date samples taken
text
C1317250 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Pregnancy Test
Item
If subject is female and of childbearing potential a serum pregnancy test must be performed.
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
Result of the ECG
integer
C1623258 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal, not clinically significant (2)
CL Item
Abnormal, clinically significant (3)
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])
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])
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
The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD
C0681889 (UMLS CUI-1)
ADAS-COG
Item
ADAS-COG Summary
text
C3539026 (UMLS CUI [1])
CIBIC-Plus Summary
Item
CIBIC-Plus Summary
text
C0443172 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Neuropsychiatric Inventory (NPI)
Item
Neuropsychiatric Inventory (NPI) Definitions for frequency, severity and distress
text
C3539727 (UMLS CUI [1])
Item Group
Investigational Product/ Compliance - Dispense Weeks 25 - 32 study medication as specified by the IVRS system. Record start date, container number and number of tablets dispensed below (stop date and tablets returned will be completed when the bottle is returned).
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Investigational Product
Item
Investigational Product (e.g Bottle 1)
text
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
integer
IP Container Number
Item
IP Container No.
text
C0180098 (UMLS CUI [1])
Total number of Tablets Dispensed
Item
Total number of Tablets Dispensed
float
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Total number of Tablets Returned
Item
Total number of Tablets Returned
float
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Discontinuation
Item
Has the subject missed 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)
End of Visit Reminder
Item
Schedule Visit 7 for 8 weeks (+/- 3 days) after this visit. It is not necessary for the subject to be fasted.
text
C1709896 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])

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