Item
Did patient become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Code List
Did patient become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (X)
CL Item
Yes a If ’Yes’ record details on Pregnancy Notification Form. (Y)
Item
Did the female partner of a male patient become pregnant during the study?
text
C0919624 (UMLS CUI [1])
Code List
Did the female partner of a male patient become pregnant during the study?
CL Item
Not applicable (subject is female, female partner not of childbearing potential or female partner) (X)
CL Item
Yes a If ’Yes’ record details on Pregnancy Notification Form. (Y)
Did the subject complete the study as planned?
Item
Did the subject complete the study as planned?
boolean
C2348577 (UMLS CUI [1])
Item
If the subject did not complete the study as planned, mark the most appropriate category
integer
C2348577 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Code List
If the subject did not complete the study as planned, mark the most appropriate category
CL Item
Adverse Event (complete Adverse Event Form) (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Deviation from Protocol (including non-compliance) (3)
CL Item
Lost to Follow-Up (4)
CL Item
Other, Please specify (5)
If other reason for not completing the study, specify
Item
If other reason for not completing the study, specify
text
C2348577 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Comments on reason for withdrawal:
Item
Comments on reason for withdrawal:
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Date of Withdrawal:
Item
Date of Withdrawal:
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Withdrawal:
Item
Time of Withdrawal:
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of Final Dose:
Item
Date of Final Dose:
date
C1762893 (UMLS CUI [1])
Time of Final Dose:
Item
Time of Final Dose:
time
C0946444 (UMLS CUI [1])
Item
Check all Adverse Event forms are up to date and complete
integer
C0877248 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Code List
Check all Adverse Event forms are up to date and complete
CL Item
All Adverse Event forms are up to date and complete (1)
Item
Check that the Concomitant Medication form is up to date
integer
C2347852 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])
Code List
Check that the Concomitant Medication form is up to date
CL Item
Concomitant Medication form is up to date (1)
Item
Check that all appropriate pages are signed (thus indicating completion) and dated
integer
C0805732 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Code List
Check that all appropriate pages are signed (thus indicating completion) and dated
CL Item
All appropriate pages are signed (thus indicating completion) and dated (1)
Item
Check that laboratory results are included
integer
C1254595 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
Code List
Check that laboratory results are included
CL Item
Laboratory results are included (1)
Investigator
Item
Investigator
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])