blood sampling date and time
Item
Exact date and time of blood sampling
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
clinical chemistry and hematology normal
Item
Are there CLINICALLY SIGNIFCANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
boolean
C0008000 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Item
Did patient become pregnant during the study?
text
C0032961 (UMLS CUI [1])
Code List
Did patient become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (X)
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)
study completed
Item
Did the subject complete the study as planned?
boolean
C2348577 (UMLS CUI [1])
Item
If NO, mark the most appropriate category
integer
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Code List
If NO, 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)
withdrawal reason
Item
If OTHER, please specify
text
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
withdrawal reason comment
Item
Comments on reason for withdrawal:
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
withdrawal date
Item
Date of Withdrawal
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
withdrawal time
Item
Time of Withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
final dose date
Item
Date of Final Dose
date
C1531784 (UMLS CUI [1])
final dose time
Item
Time of Final Dose
time
C0013227 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])