Patient take
Item
1. Did the patient take at least 75% of each trial medication
boolean
C0013227 (UMLS CUI [1])
Item
2. If NO, which medication was the patient non compliant with (please indicate all that apply):
integer
C0030705 (UMLS CUI [1,1])
C0457432 (UMLS CUI [1,2])
Code List
2. If NO, which medication was the patient non compliant with (please indicate all that apply):
CL Item
Blister card C (3)
CL Item
Blister card D (4)
Discontinuation Of Trial Medication
Item
3. Since the last visit did the patient discontinue trial medication?
boolean
C0013227 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
If YES
Item
4. If YES, was this a permanent discontinuation?
boolean
C0457454 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
Item
Drug (1-ABC, 2-D, 3-ABCD)
integer
C0013227 (UMLS CUI [1])
Code List
Drug (1-ABC, 2-D, 3-ABCD)
Date Stopped
Item
Date Stopped (dd mon yy)
date
C1531784 (UMLS CUI [1])
Date Restarted
Item
Date Restarted (mon dd yy)
date
C3173309 (UMLS CUI [1])
Trial Medication due to an Adverse Event
Item
Was trial medication temporarily stopped due to an Adverse Event?
boolean
C0877248 (UMLS CUI [1,1])
C1531784 (UMLS CUI [1,2])
if Yes
Item
If YES enter Adverse Event Name
text
C0877248 (UMLS CUI [1])
Review Patient Visit
Item
patient is to continue taking trial medication from kit dispensed at visit 1. Please review patient visit calendar, and confirm date of next visit.
text
C0545082 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Signature
Item
6. Signature of Investigator or Sub-Investigator By Sgning and dating this page, I declare that I have reviewed for accuracy all the case report form pages for this patient visit; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed on the specified dates.
text
C1519316 (UMLS CUI [1])
Date
Item
Date of Signature (dd mon yy)
date
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])