Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Has the patient become pregnant to date?
text
C0549206 (UMLS CUI [1])
Code List
Has the patient become pregnant to date?
CL Item
Not applicable (not of childbearing potential or male) (X)
Item
Is the patient continuing in the study?
text
C2348568 (UMLS CUI [1])
Code List
Is the patient continuing in the study?
Item
If patient is not continuing in the study, please mark the primary cause of withdrawal
integer
C1549995 (UMLS CUI [1])
Code List
If patient is not continuing in the study, please mark the primary cause of withdrawal
CL Item
Adverse experience (please complete AE page) (1)
CL Item
Does not meet inclusion/exclusion criteria (2)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
Other reason
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1])
consent form
Item
I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Adverse Experience and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.
boolean
C0009797 (UMLS CUI [1])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])