Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
number of SAE
Item
Specify total number of SAE´s:
text
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
elimination criteria
Item
Did any elimination criteria become applicable during the study? If Yes, please specify
boolean
C0680251 (UMLS CUI [1])
elimination criteria
Item
Did any elimination criteria become applicable during the study? If Yes, please specify
text
C0680251 (UMLS CUI [1])
withdrawn
Item
Was the subject withdrawn from study?
boolean
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
Major reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Major reason for withdrawal
CL Item
Non Serious adverse event (AEX)
CL Item
Consent withdrawal not due to an adverse event (CWS)
CL Item
Lost to follow up (LFU)
CL Item
Migrated moved from the study area (MIG)
CL Item
Protocol violation (PTV)
CL Item
Serious adverse event (SAE)
Item
Who made the decision:
integer
C0679006 (UMLS CUI [1])
Code List
Who made the decision:
CL Item
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Item
Was the subject in good condition at date of last contact
integer
C0348080 (UMLS CUI [1])
Code List
Was the subject in good condition at date of last contact
CL Item
No, Please give details in Adverse Events section. (1)
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
Printed Investigators name
Item
Printed Investigators name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])