Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item
Did the subject have an unscheduled visit?
text
C0545082 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Code List
Did the subject have an unscheduled visit?
Item
Did the subject receive investigational product?
text
C0304229 (UMLS CUI [1])
Code List
Did the subject receive investigational product?
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Did the subject experience any serious adverse events during the study?
Item
Did the subject receive ITP therapy?
text
C0398650 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Code List
Did the subject receive ITP therapy?
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications affecting ocular health taken by the subject during the study?
text
C2347852 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1299003 (UMLS CUI [1,3])
C0018759 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,5])
C0008976 (UMLS CUI [1,6])
Code List
Were any concomitant medications affecting ocular health taken by the subject during the study?
Item
Were any blood products and blood supportive care products taken by the subject?
text
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0018938 (UMLS CUI [2,2])
Code List
Were any blood products and blood supportive care products taken by the subject?
Item
Did the subject have any medical/surgical procedures during the study?
text
C1948041 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Did the subject have any medical/surgical procedures during the study?
Item
Was subject unblinded as a result of an emergency?
text
C2826259 (UMLS CUI [1,1])
C0013956 (UMLS CUI [1,2])
Code List
Was subject unblinded as a result of an emergency?
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
text
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
Code List
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?