Did the subject experience any Serious Adverse Event during the study period?
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
If Yes, specify total number of SAE's
Item
If Yes, specify total number of SAE's
integer
Did any elimination criteria become applicable during the study?
Item
Did any elimination criteria become applicable during the study?
boolean
If Yes, specify
Item
If Yes, specify
text
Was the subject withdrawn from study?
Item
Was the subject withdrawn from study?
boolean
Item
If Yes, please tick the ONE most appropriate category for withdrawal
text
Code List
If Yes, please tick the ONE most appropriate category for withdrawal
CL Item
Serious Adverse Event (1)
CL Item
Non-Serious Adverse Event (2)
CL Item
Protocol violation (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 Other, please specify
Item
If Other, please specify
text
Item
Who took the decision to withdraw?
text
Code List
Who took the decision to withdraw?
CL Item
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
Was the subject in good condition at the date of last contact?
Item
Was the subject in good condition at the date of last contact?
boolean
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.
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
Investigator's signature
Item
Investigator's signature
text
Investigator's name (in print)
Item
Investigator's name (in print)
text