Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Non-serious Adverse Event, During, Clinical Trials
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Non-serious Adverse Event, Diagnosis, Symptoms
Item
Non-serious adverse events - Diagnosis only (if known) or signs / symptoms
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Non-serious Adverse Event, Start Date
Item
Date of onset
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-serious Adverse Event, Start Time
Item
Time of onset
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Maximum intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Maximum intensity
CL Item
Not applicable (4)
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
CL Item
Resolved with sequelae (2)
Non-serious Adverse Event, End Date
Item
Date of resolution
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-serious Adverse Event, End Time
Item
Time of resolution
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Action taken with investigational product(s) as a result of the non-serious AE
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
Dose adjusted (2)
CL Item
Temporarily interrupted (3)
CL Item
Permanently discontinued (4)
CL Item
Not applicable (5)
Non-serious Adverse Event, Withdraw
Item
Did subject withdraw from study as a result of this non-serious AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Non-serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event
Item
Does the AE meet the definition of serious?
boolean
C1519255 (UMLS CUI [1])