Occurence of Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event?
integer
C1519255 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Number of SAE's
Item
Specify total number of SAE's
integer
Elimination Criteria
Item
Did any elimination criteria become applicable?
boolean
C0680251 (UMLS CUI [1])
Elimination Criteria Specification
Item
Specify
text
Study Withdrawal
Item
Was the subject withdrawn from the study?
integer
C0422727 (UMLS CUI [1])
Item
Major reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Major reason for withdrawal
CL Item
Serious Adverse Event (SAE)
CL Item
Non-Serious Adverse Event (AEX)
CL Item
Protocol Violation Specify (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 No.
Item
Please specify SAE No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE No.
Item
Please specify AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited AE Code
Item
Solicited AE code
integer
C1518404 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Protocol Violation Specification
Item
Protocol violation, please specify
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other Specification
Item
Other, please specify
text
C0205394 (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])
Subjects Condition at Last Contact
Item
Was the subject in good condition at date of last contact?
boolean
C0805839 (UMLS CUI [1,1])
C1142435 (UMLS CUI [1,2])
Investigator's Signature
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.
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigators Name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])