Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Protocol number
Item
Protocol number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Future studies
Item
If a booster study or a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
boolean
C0020975 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C1955348 (UMLS CUI [1,4])
C0016441 (UMLS CUI [2,1])
C0337611 (UMLS CUI [2,2])
C1955348 (UMLS CUI [2,3])
Item
If NO, Please tick the most appropriate reason:
text
C0008976 (UMLS CUI [1,1])
C0016884 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Code List
If NO, Please tick the most appropriate reason:
CL Item
adverse events or serious adverse events (a)
Specify the most appropriate reason for non-participation in future studies
Item
Specify the most appropriate reason choosen above:
text
C0008976 (UMLS CUI [1,1])
C0016884 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
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 SAEs
Item
If the subject experienced SAEs, please specify the total number of SAEs:
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Pregnancy information
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
Status of treatment blind
Item
Was the treatment blind broken during the study?
boolean
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Date of Unblinding
Item
If the treatment blind was broken during the study, please complete the date:
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Tick the reason, why the treatment blind was broken during the study:
text
C0566251 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Code List
Tick the reason, why the treatment blind was broken during the study:
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
Specify 'Other' reason for unblinding
Item
Specify 'Other' reason for unblinding:
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Elimination Criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
Specify applicable elimination criteria
Item
If any elimination criteria became applicable during the study, please specify:
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Withdrawal
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Please tick ONE major reason for withdrawal:
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Please tick ONE 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 adverse event (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
SAE number
Item
If SAE was the major reason for withdrawal, please complete SAE number:
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE number
Item
If Non-Serious adverse event was the major reason for withdrawal, please complete AE Number:
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited AE code
Item
If Non-Serious adverse event was the major reason for withdrawal, please complete solicited AE code:
text
C1518404 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Protocol violation
Item
If Protocol violation was the major reason for withdrawal from the study, please specify:
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Specify other reason for withdrawal from the study
Item
If 'Other' was the major reason for withdrawal from the study, please specify:
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])