Follow-Up Studies
Item
If a booster study or a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
boolean
C0016441 (UMLS CUI [1])
Item
Please specify the most appropriate reason
text
C0566251 (UMLS CUI [1])
Code List
Please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (Adverse Events, or Serious Adverse Events)
Adverse Events or Serious Adverse Events
Item
Please specify
text
C0877248 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Other
Item
Please specify
text
C0205394 (UMLS CUI [1])
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
Status of Treatment Blind
Item
Was the treatment blind broken during the study?
boolean
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Date Treatment Blind Broken
Item
Complete date and tick one reason below.
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Complete date and tick one reason below.
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Complete date and tick one reason below.
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
Other Specification
Item
Specify
text
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])