Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
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
Parents/Guardians (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Was the subject withdrawn from the study?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
Please tick the ONE most appropriate category for withdrawal.
text
C2349954 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Code List
Please tick the ONE most appropriate category for withdrawal.
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])
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])