ID

17574

Descrição

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)

Palavras-chave

  1. 11/09/2016 11/09/2016 -
  2. 25/09/2016 25/09/2016 -
Transferido a

25 de setembro de 2016

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC-ND 3.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

REFELCT-1 Visit 6 NCT00428090

REFLECT-1 Visit 6 NCT00428090

Patient Information
Descrição

Patient Information

Alias
UMLS CUI-1
C1955348
Subject Identifier
Descrição

Patient Study ID

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descrição

Visit Date

Tipo de dados

date

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

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.
Descrição

Central Laboratory Instructions

Tipo de dados

text

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

Investigator Instructions

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

Investigator Instructions

Tipo de dados

text

Alias
UMLS CUI [1]
C1442085
Subject Continuation
Descrição

Subject Continuation

Alias
UMLS CUI-1
C0805733
If the subject is not continuing in the study, complete all assessments for this visit, ans 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. Esnure 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.
Descrição

Subject Continuation

Tipo de dados

text

Alias
UMLS CUI [1]
C0805733
Vital signs
Descrição

Vital signs

Alias
UMLS CUI-1
C0518766
Weight
Descrição

Weight

Tipo de dados

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.
Descrição

Systolic Blood Pressure

Tipo de dados

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.
Descrição

Diastolic Blood Pressure

Tipo de dados

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.
Descrição

Patient Position

Tipo de dados

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.
Descrição

Heart Rate

Tipo de dados

float

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

Neurologic Examination

Alias
UMLS CUI-1
C0027853
Perform a Neurologic examination on hte 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 No-Serious Adverse Events page.
Descrição

Neurologic Examination

Tipo de dados

text

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

Central Laboratory (Non Fasting Samples)

Alias
UMLS CUI-1
C1880016
Dates sample taken
Descrição

Dates sample taken

Tipo de dados

date

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

Pregnancy Test

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

Pregnancy Test

Tipo de dados

text

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

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Descrição

Date of ECG

Tipo de dados

date

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

Result of the ECG

Tipo de dados

text

Alias
UMLS CUI [1]
C0438154
Concomitant Medication
Descrição

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.
Descrição

Concomitant medication

Tipo de dados

text

Alias
UMLS CUI [1]
C2347852
Adverse Event
Descrição

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.
Descrição

Adverse Event

Tipo de dados

text

Alias
UMLS CUI [1]
C0877248
Physical Examination
Descrição

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.
Descrição

Physical Examination

Tipo de dados

text

Alias
UMLS CUI [1]
C0031809
Pedal Oedema
Descrição

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:
Descrição

Pedal Oedema: depth

Tipo de dados

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:
Descrição

Pedal Oedema: Site

Tipo de dados

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
Descrição

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
Descrição

ADAS-cog Summary

Tipo de dados

text

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

CIBIC-Plus Summary

Tipo de dados

text

Neuropsychiatric Inventory (NPI)
Descrição

Neuropsychiatric Inventory (NPI)

Tipo de dados

text

Alias
UMLS CUI [1]
C3539727
Investigational Product - 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).
Descrição

Investigational Product - 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
Investigational Product (e.g Bottle 1)
Descrição

Investigational Product

Tipo de dados

text

Alias
UMLS CUI [1]
C0304229
Start Date
Descrição

Start Date

Tipo de dados

date

Unidades de medida
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0808070
dd/MMM/yy
Stop Date
Descrição

Stop Date

Tipo de dados

date

Unidades de medida
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0806020
dd/MMM/yy
Dose
Descrição

Dose

Tipo de dados

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C3174092
mg
IP Container No.
Descrição

IP Container No.

Tipo de dados

float

Alias
UMLS CUI [1]
C0180098
Has the subject missed investigational product for > 7 consecutive days?
Descrição

Discontinuation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0457454
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).
Descrição

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
C1321605
Total number of Tablets Dispensed
Descrição

Total number of Tablets Dispensed

Tipo de dados

float

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

Total number of Tablets Returned

Tipo de dados

float

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
End of Visit Reminder
Descrição

End of Visit Reminder

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

End of Visit Reminder

Tipo de dados

text

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

Similar models

REFLECT-1 Visit 6 NCT00428090

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
Telephone the IVRS system to register the visit. (Note that if the subject is not continuiing in the study, you should make a Withdrawal call rather than a Visit Registration call). Review study medication compliance.
text
C1442085 (UMLS CUI [1])
Item Group
Subject Continuation
C0805733 (UMLS CUI-1)
Subject Continuation
Item
If the subject is not continuing in the study, complete all assessments for this visit, ans 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. Esnure 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
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 hte 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 No-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 - 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)
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
float
C3174092 (UMLS CUI [1])
IP Container No.
Item
IP Container No.
float
C0180098 (UMLS CUI [1])
Discontinuation
Item
Has the subject missed investigational product for > 7 consecutive days?
boolean
C0457454 (UMLS CUI [1])
Item Group
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).
C1321605 (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])
Item Group
End of Visit Reminder
C1709896 (UMLS CUI-1)
C1320303 (UMLS CUI-2)
End of Visit Reminder
Item
Schedule Visit 7 for 8 weeeks (+- 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])

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial