Date of subject completion of withdrawal
Item
Date of subject completion of withdrawal
date
C2983670 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
Item
Was the subject withdrawn from study?
text
C0422727 (UMLS CUI [1])
Code List
Was the subject withdrawn from study?
Item
If the subject was withdrawn from trial, what was the primary reason?
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
If the subject was withdrawn from trial, what was the primary reason?
CL Item
Adverse Event (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
Lack of efficacy (5)
CL Item
Sponsor terminated study (6)
Item
If other primary reason for withdrawal, specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
If other primary reason for withdrawal, specify
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Code List
Did the subject become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (X)
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 of Investigator's signature
Item
Date of Investigator's signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's Name
Item
Investigator's Name (print)
text
C2826892 (UMLS CUI [1])