Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1])
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Not Applicable (Check Not Applicable if female partner not of childbearing potential or no female partner (X)
Was the treatment blind broken during the study?
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
If treatment blind was broken, record date/time blind broken
Item
If treatment blind was broken, record date/time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (Z)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Code List
Was the subject withdrawn from the study?
CL Item
Yes, complete complete primary reason for withdrawal (Y)
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 Events forms as appropriate) (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow-up (6)
CL Item
Investigator discretion, specify (select this reason if none of the other primary reasons are appropriate) (7)
CL Item
Withdrew consent (8)
Specify Investigator discretion
Item
Specify Investigator discretion
text
C2348235 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
Item
Case book ready for signature
text
C1706256 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Code List
Case book ready for signature
CL Item
Yes (Data owner should check thebox when data cleaning is complete) (Y)