Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Date and time of onset
Item
Date and time of onset (Record time only on day of infusion)
datetime
C0332162 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Date and time of resolution
Item
Date and time of resolution (if resolved, record time only on day of infusion)
datetime
C1264639 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
Relationship to study drug
Item
Relationship to study drug
boolean
C0013227 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Item
Severity
text
C1710066 (UMLS CUI [1])
Item
Action take with study drug
text
C3819139 (UMLS CUI [1])
Code List
Action take with study drug
Treatment required
Item
Treatment required (If Yes, record on the appropriate Concomitant Therapy form)
boolean
C2981656 (UMLS CUI [1])
Serious adverse event
Item
Mark ONLY if this is a SERIOUS ADVERSE EVENT (complete an SAE form)
boolean
C1519255 (UMLS CUI [1])
Adverse event reason for withdrawal
Item
Mark ONLY if this adverse event is the reason for the subject's withdrawal from study
boolean
C0877248 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Infection
Item
Mark ONLY if this is an infection
boolean
C0009450 (UMLS CUI [1])