Item
Was the treatment blind broken during the study?
text
C2347038 (UMLS CUI [1])
Code List
Was the treatment blind broken during the study?
Date blind broken
Item
Date blind broken
date
C0011008 (UMLS CUI [1])
Item
Reason blind broken
text
C0392360 (UMLS CUI [1])
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
If
Item
If "Other", please specify:
text
C0392360 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Date of subject completion or date of subject withdrawal
Item
Date of subject completion or date of subject withdrawal
date
C2983670 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Code List
Was the subject withdrawn from the study?
Item
If "Yes", select primary reason for withdrawal
text
C0392360 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Code List
If "Yes", select primary reason for withdrawal
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)
CL Item
Disease progression (7)
If "other", specify:
Item
If "other", specify:
text
C0392360 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])