ID

17582

Descripción

NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

Palabras clave

  1. 25/9/16 25/9/16 -
Subido en

25 de septiembre de 2016

DOI

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Licencia

Creative Commons BY-NC-ND 3.0

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REFLECT-1 Visit 9 NCT00428090

REFLECT-1 Visit 9 NCT00428090

Patient Information
Descripción

Patient Information

Alias
UMLS CUI-1
C1955348
Subject Identifier
Descripción

Patient Study ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

Unidades de medida
  • dd/MMM/yy
Alias
UMLS CUI [1]
C1320303
dd/MMM/yy
Central Laboratory Instructions
Descripción

Central Laboratory Instructions

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

Central Laboratory Instructions

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C1442085
Investigator Instructions
Descripción

Investigator Instructions

Alias
UMLS CUI-1
C1442085
Please make a Completion call to the IVRS system.
Descripción

Investigator Instructions

Tipo de datos

text

Alias
UMLS CUI [1]
C1442085
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
Systolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Descripción

Systolic Blood Pressure

Tipo de datos

float

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Descripción

Diastolic Blood Pressure

Tipo de datos

float

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Patient Position: Sitting. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Descripción

Patient Position

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0449850
Heart rate. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Descripción

Heart Rate

Tipo de datos

float

Unidades de medida
  • Beats/Min
Alias
UMLS CUI [1]
C0018810
Beats/Min
Neurologic Examination
Descripción

Neurologic Examination

Alias
UMLS CUI-1
C0027853
Perform a Neurologic examination on the subject, including assessment of gait balance, coordination, cranial nerves and mtor and sensory systems. 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

Neurologic Examination

Tipo de datos

text

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

Central Laboratory (Non Fasting Samples)

Alias
UMLS CUI-1
C1880016
Dates sample taken
Descripción

Dates sample taken

Tipo de datos

date

Unidades de medida
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0460065
dd/MMM/yy
Pregnancy Test
Descripción

Pregnancy Test

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

Pregnancy Test

Tipo de datos

text

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

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Descripción

Date of ECG

Tipo de datos

date

Unidades de medida
  • dd/MMM/yy
Alias
UMLS CUI [1]
C2826640
dd/MMM/yy
Result of the ECG
Descripción

Result of the ECG

Tipo de datos

text

Alias
UMLS CUI [1]
C0438154
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 apporpriate Concomitant Medications sections.
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

text

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

text

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

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

Alias
UMLS CUI-1
C0681889
ADAS-cog Summary
Descripción

ADAS-cog Summary

Tipo de datos

text

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

CIBIC-Plus Summary

Tipo de datos

text

Neuropsychiatric Inventory (NPI)
Descripción

Neuropsychiatric Inventory (NPI)

Tipo de datos

text

Alias
UMLS CUI [1]
C3539727
Investigational Product Compliance
Descripción

Investigational Product Compliance

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1321605
Turn to the Investigational Product Compliance section for the previous visit to record the stop dates and number of tablets returned and to answer the question "Has the subject missed taking investigational product for > 7 consecutive days"?
Descripción

Investigational Product Compliance

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1321605
Total number of Tablets Dispensed
Descripción

Total number of Tablets Dispensed

Tipo de datos

float

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

Total number of Tablets Returned

Tipo de datos

float

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

Discontinuation

Tipo de datos

boolean

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

End of Visit Reminder

Alias
UMLS CUI-1
C1709896
UMLS CUI-2
C1320303
Ensure the following sections are fully completed at this time: - Concomitant Medication - Non-serious Adverse Events - Pharmacogenetic and Pharmacoenomic Research - Study Conclusion Schedule a study end safety follow-up visit for 14 +- days after this visit.
Descripción

End of Visit Reminder

Tipo de datos

text

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

Similar models

REFLECT-1 Visit 9 NCT00428090

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Study ID
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
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 the fasting state (No food or dring (except water) for at least 8 hours prior to sampling). If the subject is not in the fasted state, do not take samples. Schedule the subject to attend the clinical in the fasted state within the next 5 days for collection for laboratory samples.
text
C1880016 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Item Group
Investigator Instructions
C1442085 (UMLS CUI-1)
Investigator Instructions
Item
Please make a Completion call to the IVRS system.
text
C1442085 (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. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
float
C0428883 (UMLS CUI [1])
Patient Position
Item
Patient Position: Sitting. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
boolean
C0449850 (UMLS CUI [1])
Heart Rate
Item
Heart rate. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
float
C0018810 (UMLS CUI [1])
Item Group
Neurologic Examination
C0027853 (UMLS CUI-1)
Neurologic Examination
Item
Perform a Neurologic examination on the subject, including assessment of gait balance, coordination, cranial nerves and mtor and sensory systems. 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
C0027853 (UMLS CUI [1])
Item Group
Central Laboratory (Non Fasting Samples)
C1880016 (UMLS CUI-1)
Dates sample taken
Item
Dates sample taken
date
C0460065 (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
text
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (Normal)
CL Item
Abnormal - not clinically significant (Abnormal - not clinically significant)
CL Item
Abnormal - clinically significant (--> Complete an Adverse Event (AE) or Serious Adverse Event (SAE) page8s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. (Abnormal - clinically significant (--> Complete an Adverse Event (AE) or Serious Adverse Event (SAE) page8s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.)
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 apporpriate Concomitant Medications sections.
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)
Pedal Oedema: depth
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:
text
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
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:
text
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
Right Ankle (Right Ankle)
CL Item
Left Ankle (Left Ankle)
Item Group
Rating Scale Instrucitions - The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD
C0681889 (UMLS CUI-1)
ADAS-cog Summary
Item
ADAS-cog Summary
text
C3539026 (UMLS CUI [1])
CIBIC-Plus Summary
Item
CIBIC-Plus Summary
text
Neuropsychiatric Inventory (NPI)
Item
Neuropsychiatric Inventory (NPI)
text
C3539727 (UMLS CUI [1])
Item Group
Investigational Product Compliance
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Investigational Product Compliance
Item
Turn to the Investigational Product Compliance section for the previous visit to record the stop dates and number of tablets returned and to answer the question "Has the subject missed taking investigational product for > 7 consecutive days"?
text
C0304229 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
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
Ensure the following sections are fully completed at this time: - Concomitant Medication - Non-serious Adverse Events - Pharmacogenetic and Pharmacoenomic Research - Study Conclusion Schedule a study end safety follow-up visit for 14 +- days after this visit.
text
C1709896 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])

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