Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Follow-Up Studies, Contact with, parent, Legal Guardians
Item
If a booster study or a follow-up study is offered in the future, would the subject/parents/guardians be willing to be contacted and learn more about it?
boolean
C0016441 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0030551 (UMLS CUI [1,3])
C0023226 (UMLS CUI [1,4])
Item
If No, please specify the most appropriate reason
text
C0016441 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0030551 (UMLS CUI [1,3])
C0023226 (UMLS CUI [1,4])
C0016441 (UMLS CUI [1,5])
C0566251 (UMLS CUI [1,6])
Code List
If No, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (please specify) (1)
CL Item
Other (please specify) (2)
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event, Count of entities
Item
If Yes, specify total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Subject Unblinding Event Record
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Subject Unblinding Event Record, Date in time
Item
Complete Date
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Tick one reason below
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Tick one reason below
CL Item
Medical emergency requiring identification of investigational product for further treatments. (1)
CL Item
Other, specify (2)
Exclusion Criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Specify
text
C0680251 (UMLS CUI [1])
Withdraw
Item
Was the subject withdrawn from the study?
boolean
C2349954 (UMLS CUI [1])
Item
Major reason for withdrawal (tick one box only).
text
C2349954 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Code List
Major reason for withdrawal (tick one box only).
CL Item
Serious adverse event (Please specify SAE N°) (1)
CL Item
Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (2)
CL Item
Protocol violation, please specify (3)
CL Item
Consent withdrawal, not due to an adverse event. (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up. (6)
CL Item
Other, please specify (7)
Withdraw, Indication, Details
Item
Specifications
text
C2349954 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item
Who made the decision
text
C2349954 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Who made the decision
CL Item
Parents/Guardians (2)
Withdraw, Date last contact
Item
Date of last contact
date
C2349954 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
Withdraw, Date last contact, General physical condition
Item
Was the subject in good condition at date of last contact?
boolean
C2349954 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,3])
Investigator Signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])