Date of 1st confirmation
Item
Date of 1st confimation
date
Remarks of 1st confirmation
Item
text
Date of 2nd confirmation
Item
Date of 2nd confirmation
date
Remarks of 2nd confirmation
Item
text
Date of 1st confimation
Item
Date of 1st confirmation
date
Remarks of 1st confirmation
Item
text
Date of 2nd confirmation
Item
Date of 2nd confirmation
date
Remarks of 2nd confirmation
Item
text
Completion
Item
Did the patient complete the study up to the end of 5 year follow-up?
boolean
Date of last contact
Item
Date of last contact
date
C0011008 (UMLS CUI [1])
Study completion
Item
Did the patient complete the study up to the end of the treatment phase?
boolean
Item
Reason for no completion
integer
Code List
Reason for no completion
CL Item
adverse event/intercurrent illness (1)
CL Item
death (complete death page) (2)
CL Item
insufficient therapeutic response (3)
CL Item
failure to return (4)
CL Item
did not cooperate/withdrew consent (5)
CL Item
administrative/other (6)
Specify violation of selection criteria
Item
text
Specify other protocol violation
Item
text
Specify other reason
Item
text
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Item
Survival status
integer
Code List
Survival status
CL Item
lost to follow-up (3)
Date of Death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Date of last contact
Item
Date last contact
date
C0805839 (UMLS CUI [1])
Item
Cause of death
integer
C0007465 (UMLS CUI [1])
CL Item
progressive disease (1)
Specify other cause of death
Item
Specify other cause of death
text
C0007465 (UMLS CUI [1])
Item
Did the patient’s disease progress after coming off study?
integer
C0242656 (UMLS CUI [1])
Code List
Did the patient’s disease progress after coming off study?
CL Item
not applicable (progressive disease already documented) (4)
Date of progressive disease
Item
Date of progressive disease
date
C1335499 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])