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NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 7

1 moduli  
General Information
Descrizione

General Information

Protocol Identifier: AVA100193
Descrizione

Protocol Identifier

Tipo di dati

boolean

Subject Identifier
Descrizione

Subject Identifier

Tipo di dati

integer

Visit Date
Descrizione

Visit Date

Tipo di dati

date

Visit Description: Visit 7
Descrizione

Visit Description

Tipo di dati

boolean

Subject Continuation
Descrizione

If the subject is not continuing in the study, complete all assessments and 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.

Tipo di dati

boolean

Vital Signs
Descrizione

Vital Signs

Weight
Descrizione

Weight

Tipo di dati

float

Unità di misura
  • kg
kg
Blood pressure: Systolic
Descrizione

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

Tipo di dati

integer

Blood pressure: Diastolic
Descrizione

Blood pressure

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Descrizione

Heart rate

Tipo di dati

integer

Unità di misura
  • bpm
bpm
Central Laboratory (Non fasting samples)
Descrizione

Central Laboratory (Non fasting samples)

Date samples taken
Descrizione

Date samples taken

Tipo di dati

date

Concomitant Medications
Descrizione

Concomitant Medications

Concomitant medications
Descrizione

Concomitant medications

Tipo di dati

text

Adverse Events
Descrizione

Adverse Events

Adverse Events
Descrizione

Adverse Events

Tipo di dati

text

Physical Examination
Descrizione

Physical Examination

Pedal Oedema
Descrizione

Pedal Oedema

Estimated Depth of Indentation
Descrizione

Estimated Depth of Indentation

Tipo di dati

text

Indicate which ankle was assessed at this visit
Descrizione

Ankle

Tipo di dati

text

Monitor Data Validation Checks
Descrizione

Monitor Data Validation Checks

Monitor Data Validation Check
Descrizione

Monitor Data Validation Check

Tipo di dati

boolean

Investigational Product
Descrizione

Investigational Product

Investigational Product
Descrizione

Investigational Product

Tipo di dati

text

Start Date
Descrizione

Start Date

Tipo di dati

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Descrizione

Stop Date

Tipo di dati

date

IP Container No.
Descrizione

IP Container No.

Tipo di dati

integer

Total Number of Tablets Dispensed
Descrizione

Total Number of Tablets Dispensed

Tipo di dati

float

Total Number of Tablets Returned
Descrizione

Total Number of Tablets Returned

Tipo di dati

float

Has the subject missed investigational product for > 7 consecutive days?
Descrizione

Discontinuation

Tipo di dati

boolean

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

End of Visit Reminder

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Similar models

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 7

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
General Information
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Visit Description
Item
Visit Description: Visit 7
boolean
Subject Continuation
Item
Subject Continuation
boolean
Item Group
Vital Signs
Weight
Item
Weight
float
Blood pressure
Item
Blood pressure: Systolic
integer
Blood pressure
Item
Blood pressure: Diastolic
integer
C0005823 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
Item Group
Central Laboratory (Non fasting samples)
Date samples taken
Item
Date samples taken
date
Item Group
Concomitant Medications
Concomitant medications
Item
Concomitant medications
text
Item Group
Adverse Events
Adverse Events
Item
Adverse Events
text
Item Group
Physical Examination
Item Group
Pedal Oedema
Item
Estimated Depth of Indentation
text
Estimated Depth of Indentation
Code List
Estimated Depth of Indentation
CL Item
< 1mm (1)
CL Item
1-2 mm (2)
CL Item
3-5 mm (3)
CL Item
6-10 mm (4)
CL Item
> 10 mm (5)
Item
Indicate which ankle was assessed at this visit
text
Ankle
Code List
Indicate which ankle was assessed at this visit
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Item Group
Monitor Data Validation Checks
Monitor Data Validation Check
Item
Monitor Data Validation Check
boolean
Item Group
Investigational Product
Investigational Product
Item
Investigational Product
text
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
IP Container No.
Item
IP Container No.
integer
Total Number of Tablets Dispensed
Item
Total Number of Tablets Dispensed
float
Total Number of Tablets Returned
Item
Total Number of Tablets Returned
float
Discontinuation
Item
Has the subject missed investigational product for > 7 consecutive days?
boolean
C0457454 (UMLS CUI [1])
Item Group
End of Visit Reminder
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