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 5
boolean
Date
Item
Date samples taken
date
All assessments completed or early withdrawal scheduled
Item
All assessments completed or early withdrawal scheduled
boolean
Blood pressure
Item
Blood pressure: Systolic
integer
Blood pressure
Item
Blood pressure: Diastolic
integer
Heart rate
Item
Heart rate
integer
Results from Physical Examination
Item
Results from Physical Examination
text
Item
Estimated Depth of Indentation
text
Code List
Estimated Depth of Indentation
Item
Indicate which ankle was assessed at this visit
text
Code List
Indicate which ankle was assessed at this visit
Scales completed
Item
All requested scales completed
boolean
Monitor Data Validation Check completed
Item
Monitor Data Validation Check completed
boolean
Investigational Product
Item
Investigational Product
text
Start Date
Item
Start Date
date
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])