Central Laboratory Instructions
Item
Blood samples to be taken for laboratory assessment only where follow-up of abnormal value(s) is indicated.
text
C1880016 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Investigator Instructions
Item
Make a Withdrawal call to the IVRS system.
text
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])
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])
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])
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
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:
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:
End of Study Assessment
Item
Ensure the following sections are fully completed at this time: - Concomitant Medication - Non-serious Adverse Events - Study Conclusion
text
C0444496 (UMLS CUI [1])