Was the treatment blind for this subject broken during the study?
Item
Was the treatment blind for this subject broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date of subject unblinding event
Item
Date of subject unblinding event
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of subject unblinding event
Item
Time of subject unblinding event
time
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason of subject unblinding event
integer
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Reason of subject unblinding event
CL Item
Medical emergency requiring identity of investigational product for further treatment (1)
Specify 'Other' reason for subject unblinding event
Item
If answer 'Other' was choosen as reason for subject unblinding event, specify:
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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])
premature discontinuation of study
Item
Did the subject discontinue the study prematurely?
boolean
C2348577 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
Item
If 'Yes', the primary reason for discontinuation:
integer
C0566251 (UMLS CUI [1,1])
C2348577 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
Code List
If 'Yes', the primary reason for discontinuation:
CL Item
Adverse event (1)
CL Item
Consent withdrawn (2)
CL Item
Lost to follow up (3)
CL Item
Protocol violation (4)
CL Item
Other (please specify below) (5)
Specification reason for discontinuation
Item
If 'Other', please specify:
text
C2348235 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C2348577 (UMLS CUI [1,3])
C1279919 (UMLS CUI [1,4])
Date of comment
Item
Date of comment
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
CRF page number
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0008961 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Investigator's statement: I confirm that I have carefully examined all entries on the 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.
C1516308 (UMLS CUI-1)
C1955348 (UMLS CUI-2)
C4288115 (UMLS CUI-3)
C2349182 (UMLS CUI-4)
Date of Investigator's signature
Item
Date of Investigator's signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's name - print
Item
Investigator's name - print
text
C2826892 (UMLS CUI [1])