Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of subject completion or discontinuation from the study
Item
Date of subject completion or discontinuation from the study
date
C2348577 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of subject completion or discontinuation from the study
Item
Time of subject completion or discontinuation from the study
time
C2348577 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study?
CL Item
Not Applicable (not of childbearing potential or male) (X)
premature discontinuation of study
Item
Did the subject discontinue the study prematurely?
boolean
C0457454 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
Primary reason for premature discontinuation
text
C0457454 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Code List
Primary reason for premature discontinuation
CL Item
Adverse event (A)
CL Item
Consent withdrawn (C)
CL Item
Lost to follow up (L)
CL Item
Protocol violation (P)
Other reason for discontinuation
Item
Specify other reason for discontinuation
text
C0457454 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Date of comment
Item
Date of comment
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
page number
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Investigator's Statement
Item
I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
boolean
C0008961 (UMLS CUI [1,1])
C1710187 (UMLS CUI [1,2])
Date of completion
Item
Date of completion
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
Investigators name
Item
Investigators name-print
text
C2826892 (UMLS CUI [1])