Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
integer
C0422727 (UMLS CUI [1])
Code List
Was the subject withdrawn from the study?
CL Item
Yes, complete details: (2)
Date of decision to withdraw
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Primary reason for withdrawal
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event forms as appropriate) (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to follow-up (6)
CL Item
Investigator discretion, specify in the next question (Select this reason if none of the other primary reasons are appropriate) (7)
CL Item
Withdrew consent (8)
Withdrawal reason Investigator discretion
Item
Primary reason for withdrawal: Investigator discretion, specify:
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Casebook ready for signature
integer
C1706256 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Code List
Casebook ready for signature