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])
Adverse Event Led to Discontinuation
Item
5. If the patient had either an adverse event which led to temporary discontinuation of trial medication, or the patient temporarily discontinued study medication for any reason for > 28days, please record details below.
text
C0877248 (UMLS CUI [1,1])
C0457454 (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])
Trial Medication Dispensed
Item
6. Was trial medication dispensed
boolean
C0947323 (UMLS CUI [1])
if Yes
Item
7. If yes, provide patient with trial medication kit assigned by IVRS. Stick the label from trial medication kits below. If labels are lost, please enter assigned numbers below:
text
Signature
Item
8. Signature of Investigator or Sub-Investigator By signing 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])