Serious Adverse Event since last study
Item
Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026 study?
boolean
C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C2242969 (UMLS CUI [1,3])
number of SAEs in current trial
Item
If Yes, specify total number of SAE's for the Malaria-039 period only
integer
C1519255 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
subject withdrawn from the study?
Item
Is the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If Yes, choose one / major reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
If Yes, choose one / 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)
If Death, please specify SAE number
Item
If Death, please specify SAE number
integer
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C2349022 (UMLS CUI [1,3])
Is Serious Adverse Event, please specify the SAE number
Item
Is Serious Adverse Event, please specify the SAE number
integer
C1519255 (UMLS CUI [1,1])
C2349022 (UMLS CUI [1,2])
If Protocol violation, please specify
Item
If Protocol violation, please specify
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
specify other reason for withdrawal
Item
If Other, please 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])
subject condition at last contact
Item
Was the subject in good condition at date of last contact?
boolean
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
Investigator's confirmation
Item
I confirm that I have reviewed the data in this Case Report 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])