Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026 study?
Item
Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026 study?
boolean
If Yes, specify total number of SAE's for the Malaria-039 period only
Item
If Yes, specify total number of SAE's for the Malaria-039 period only
integer
Is the subject withdrawn from the study?
Item
Is the subject withdrawn from the study?
boolean
Item
If Yes, choose one reason for withdrawal
text
Code List
If Yes, choose one reason for withdrawal
CL Item
Serious adverse event (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)
If Death, please specify SAE number
Item
If Death, please specify SAE number
integer
Is Serious Adverse Event, please specify the SAE number
Item
Is Serious Adverse Event, please specify the SAE number
integer
If Protocol violation, please specify
Item
If Protocol violation, please specify
text
If Other, please specify
Item
If Other, please specify
text
Item
Who made the decision?
text
Code List
Who made the decision?
CL Item
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
Was the subject in good condition at date of last contact?
Item
Was the subject in good condition at date of last contact?
boolean
If No, please give details in Adverse Event section.
Item
If No, please give details in Adverse Event section.
text
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
Investigator's signature
Item
Investigator's signature
text
Investigator's name (in print)
Item
Investigator's name (in print)
text