Serious Adverse Events
Item
Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026?
boolean
C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C2242969 (UMLS CUI [1,3])
Number of SAEs in current trial
Item
Specify total number of SAEs for the Malaria 039 period only
integer
C1519255 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Subject withdrawn?
Item
Is the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Major reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Major reason for withdrawal
CL Item
Serious adverse event (SAE)
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)
In case of death, please specify SAE number
Item
In case of death, please specify SAE number
integer
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,3])
In case of serious adverse event, specify SAE number
Item
In case of serious adverse event, specify SAE number
integer
C1519255 (UMLS CUI [1,1])
C2349022 (UMLS CUI [1,2])
In case of protocol violation, specify
Item
In case of protocol violation, specify
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
specify other reason for withdrawal
Item
In other cases, specify
text
C2348235 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0422727 (UMLS CUI [1,4])
Item
Who made the decision
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Who made the decision
CL Item
Parents/Guardians (P)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject in good condition at date of last contact?
text
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
Code List
Was the subject in good condition at date of last contact?
Investigator's confirmation
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
date
C0750484 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's name (in print)
Item
Investigator's name (in print)
text
C2826892 (UMLS CUI [1])