Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study?
CL Item
Not Applicable (not of childbearing potential or male) (X)
Completion, Withdrawal
Item
Date of subject completion or withdrawal
date
C0805732 (UMLS CUI [1])
C2349954 (UMLS CUI [2])
Item
Was the subject withdrawn from the study?
text
C2349954 (UMLS CUI [1])
Code List
Was the subject withdrawn from the study?
Item
If Yes, tick the primary reason for withdrawal:
text
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Code List
If Yes, tick the primary reason for withdrawal:
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropirate) (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (6)
CL Item
Non-compliance (17)
Primary Reason of Withdrawal Specification
Item
If Yes, tick the primary reason for withdrawal: If Other, specify:
text
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Investigature's name
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. Investigator's name (print)
text
C2346576 (UMLS CUI [1])
Date of Report
Item
Date of Report
date
C1302584 (UMLS CUI [1])