Item
Did the subject experience any Serious Adverse Event through "Day 42"/ during the study period?
text
C1519255 (UMLS CUI [1])
Code List
Did the subject experience any Serious Adverse Event through "Day 42"/ during the study period?
SAE Number
Item
If subject experienced any SAE, please specify total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item
Did the subject become pregnant through "Day 42"/during the study period?
text
C0032961 (UMLS CUI [1])
Code List
Did the subject become pregnant through "Day 42"/during the study period?
CL Item
Not Applicable (Male only). (NA)
Item
Did any elimination criteria become applicable through "Day 42"/during the study period?
text
C0680251 (UMLS CUI [1])
Code List
Did any elimination criteria become applicable through "Day 42"/during the study period?
Elimination criteria, specification
Item
If any elimination criteria became applicable, please specify
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item
Was the subject withdrawn from the active phase/Follow-up phase?
text
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Code List
Was the subject withdrawn from the active phase/Follow-up phase?
Item
If the subject was withdrawn, please tick the major reason for withdrawal
text
C1549995 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
If the subject was withdrawn, please tick the major reason for withdrawal
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
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)
SAE Number
Item
If you tick SAE as major reason for withdrawl, please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number/ solicited AE code
Item
If you tick AE as major reason for withdrawl, please specify AE Number OR solicited AE code
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
Protocol violation, specification
Item
If you tick protocol violation as major reason for withdrawl, please specify
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other reason, specification
Item
If you tick other as major reason for withdrawl, please specify
text
C3840932 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Who made the decision?
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Who made the decision?
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])
Code List
Was the subject in good condition at date of last contact?
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])