Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
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 during the study, enter date/ time blind broken.
Item
If treatment blind was broken during the study, enter date/ time blind broken.
datetime
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C3897431 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Item
Reason blind broken
integer
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 (2)
If other reason blind broken, please specify
Item
If other reason blind broken, please specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
If subject was withdrawn from study, please record date of decision to withdraw
Item
If subject was withdrawn from study, please record date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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 form 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)
If investigator discretion, please specify
Item
If investigator discretion, please specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1])
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 (X)