Centre number
Item
Centre number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Treatment number
Item
Treatment number
text
C1522541 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Did the subject experience any Serious Adverse Event during screening? (only SAE related to study participation or to a concurrent medication need to be considered and reported)
text
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
Code List
Did the subject experience any Serious Adverse Event during screening? (only SAE related to study participation or to a concurrent medication need to be considered and reported)
CL Item
Yes, specify total number of SAEs (Y)
Number of SAEs during screening
Item
If yes, specify total number of SAEs
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1710477 (UMLS CUI [1,4])
Item
Is the subject a screening failure? (Was the subject withdrawn prior to randomization or first vaccination?)
text
C1710476 (UMLS CUI [1])
C0422727 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0034656 (UMLS CUI [2,3])
C0422727 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
C0205435 (UMLS CUI [3,3])
C0042196 (UMLS CUI [3,4])
Code List
Is the subject a screening failure? (Was the subject withdrawn prior to randomization or first vaccination?)
CL Item
Yes, provide major reason for failure (Y)
Item
If yes, provide Major reason for failure (tick one box only)
text
C1710476 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
If yes, provide Major reason for failure (tick one box only)
CL Item
Eligibility criteria not fulfilled (inclusion and exclusion criteria; please tick failing criteria on Eligibility form) (ELI)
CL Item
Protocol violation, please specify (PTV)
CL Item
Serious Adverse Event (please complete and submit SAE report and specify SAE No.) (SAE)
CL Item
Consent withdrawal / not willing to participate, not due to a serious adverse event (CWS)
CL Item
Migrated /moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other, please specify (OTH)
Reason for screening failure: protocol violation
Item
If protocol violation, please specify
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1709750 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Reason for screening failure: SAE
Item
If SAE please specify SAE No.
integer
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Other reason for screening failure
Item
If other reason, please specify
text
C1710476 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Who made the decision?
text
C0679006 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
Code List
Who made the decision?
CL Item
Parents/Guardian (P)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Date of investigator's signature
Item
Date
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])