Occurrence of Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1])
Total number of Serious Adverse Events
Item
Total number of Serious Adverse Events
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Status of Treatment Blind
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Status of Treatment Blind Broken Date
Item
Status of Treatment Blind Broken Date
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason for Treatment Blind Broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason for Treatment Blind Broken
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
Other reason for Treatment Blind Broken
Item
Other reason for Treatment Blind Broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Elimination Criteria Applicable
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
Specification of Elimination Criteria
Item
Why did any elimination criteria became applicable?
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Was the subject withdrawn?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Major reason for withdrawal .
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Major reason for withdrawal .
CL Item
serious adverse event ([SAE])
CL Item
Non-serious adverse event ([AEX])
CL Item
Protocol violation ([PTV])
CL Item
Consent withdrawal, not due to an advere event ([CWS])
CL Item
Migrated/moved from the study area ([MIG])
CL Item
Lost to follow-up ([LFU])
Serious Adverse Event Number
Item
SAE No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-serious adverse Event Number
Item
AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specification of protocol violation
Item
Specification of protocol violation
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other reason for withdrawal
Item
Other reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Who made the decision to withdraw the subject?
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0680379 (UMLS CUI [1,3])
Code List
Who made the decision to withdraw the subject?
CL Item
Investigator ([I])
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Subject Condition at Date of Last Contact
Item
Was the subject in good condition at date of last contact?
boolean
C0805839 (UMLS CUI [1,1])
C1142435 (UMLS CUI [1,2])
Specification of Subject Condition
Item
Specify the condition at date of last contact?
text
C0805839 (UMLS CUI [1,1])
C1142435 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Investigator's signature date
Item
Investigator's signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])