Item
Did a female partner ofthe male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1])
Code List
Did a female partner ofthe male subject become pregnant during the study?
CL Item
Not Applicable (subject is female, female partner not of childbearing potential or no female partner) (X)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0011008 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C1549507 (UMLS CUI [1,3])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Primary reason for withdrawal
CL Item
Adverse event --> Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. (1)
CL Item
Protocol deviation (2)
CL Item
Subject reached protocol defined stopping criteria (3)
CL Item
Study closed/terminated (4)
CL Item
Lost to follow-up (5)
CL Item
Investigator discretion (Only check if none of the other primary reasons are appropriate), specify (6)
CL Item
Withdrew consent (Only check if none of the other primary reasons are appropriate) (7)
Specify Investigator diecretion
Item
Specify Investigator diecretion
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CRF page number if applicable
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Investigator Comment
Item
Investigator Comment
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
lnvestigator's signature
Item
lnvestigator's signature
text
C2346576 (UMLS CUI [1])
lnvestigator's name (print)
Item
lnvestigator's name (print)
text
C2826892 (UMLS CUI [1])
lnvestigator's signature date
Item
lnvestigator's signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])