Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Code List
Was the treatment blind broken during the study?
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time blind broken
Item
Time blind broken
date
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
Other Reason, specification
Item
If other Reason, please specify
text
C3897431 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Was the investigational product stopped permanently before the scheduled end of the treatment period?
text
C0444930 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Was the investigational product stopped permanently before the scheduled end of the treatment period?
Item
Select primary reason the investigational product was stopped
text
C0566251 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Select primary reason the investigational product was stopped
CL Item
Adverse Event (1)
CL Item
ECG abnormality (2)
CL Item
Protocol Deviation (3)
CL Item
Study closed/terminated (4)
CL Item
Lost to Follow-up (5)
CL Item
Investigator discretion (6)
CL Item
Decision by subject or proxy (7)
Other reason, specification
Item
If other reason for stopping investigational product, please specify
text
C3840932 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C2349954 (UMLS CUI [1])
Code List
Was the subject withdrawn from the study?
Date of decision to withdraw
Item
Date of decision to withdraw
date
C2349954 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Primary reason for withdrawal
CL Item
Adverse Event (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 (7)
CL Item
Withdrew consent (8)
Withdrawal, Investigator discretion, specification
Item
If primary reason for withdrawal is Investigator discretion, please specify
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C0008961 (UMLS CUI [1,5])
Item
Is the subject alive?
text
C2584946 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Code List
Is the subject alive?
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Item
Primary cause of death
integer
C0007465 (UMLS CUI [1])
Code List
Primary cause of death
CL Item
Events common to stoke (1)
CL Item
Other cause of death (2)
Cause of death, specification
Item
Cause of death, specification
text
C2348235 (UMLS CUI [1,1])
C0007465 (UMLS CUI [1,2])
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study?
Item
Did a female partner of the male subject become pregnant during the study?
text
C0086287 (UMLS CUI [1,1])
C3887537 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Not Applicable (X)