Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Code List
Did the subject experience any non-serious adverse events during the study?
Non-serious adverse event
Item
Non-serious adverse events: Diagnosis only (if known) or signs / symptoms (list one per line)
text
C1518404 (UMLS CUI [1])
Date of onset
Item
Date of onset
text
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
NCI-CTCAE toxicity
integer
C3887242 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
NCI-CTCAE toxicity
CL Item
Not applicable (4)
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
CL Item
Resolved with sequelae (S)
Date of resolution
Item
Date of resolution
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Action taken with investigational product(s) as a result of the non-serious AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
Dose adjusted (1)
CL Item
Temporarily interrupted (2)
CL Item
Permanently discontinued (3)
CL Item
Not applicable (4)
Item
Did subject withdraw from study as a result of this non-serious AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Did subject withdraw from study as a result of this non-serious AE?
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Code List
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
Item
Does the AE meet the definition of serious?
text
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Does the AE meet the definition of serious?