Item
Did patient become pregnant during the study? (mark one box below) -> If "yes" record details on Pregnancy Notification Form
integer
C0032961 (UMLS CUI [1])
Code List
Did patient become pregnant during the study? (mark one box below) -> If "yes" record details on Pregnancy Notification Form
CL Item
Not applicable (not of childbearing potential) (1)
Item
Did the female partner of a male patient become pregnant during the study? (mark one box below) --> if "yes" record details on Pregnancy Notification Form.
integer
C1960468 (UMLS CUI [1])
Code List
Did the female partner of a male patient become pregnant during the study? (mark one box below) --> if "yes" record details on Pregnancy Notification Form.
CL Item
Not applicable (subject is female, female partner not of childbearing potential or female partner) (1)
Study completion
Item
Did the patient complete the study as planned?
boolean
C2826674 (UMLS CUI [1])
Item
If "no", mark the one most appropriate category
integer
C2348235 (UMLS CUI [1])
Code List
If "no", mark the one 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)
Other diseases
Item
Please specify "Other"
text
C2359476 (UMLS CUI [1])
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])
therapy end date
Item
Date of Final Dose:
date
C1531784 (UMLS CUI [1])
Pharmaceutical Preparations
Item
Time of Final Dose
time
C0013227 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])