Baseline event
Item
Baseline event
text
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2])
Onset Date and Time
Item
Onset Date and Time
datetime
C0808070 (UMLS CUI [1])
C1301880 (UMLS CUI [2])
C0441471 (UMLS CUI [3,1])
C1442488 (UMLS CUI [3,2])
End Date and Time
Item
End Date and Time
datetime
C0806020 (UMLS CUI [1])
C1522314 (UMLS CUI [2])
C0441471 (UMLS CUI [3,1])
C1442488 (UMLS CUI [3,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
C0441471 (UMLS CUI [2,1])
C1442488 (UMLS CUI [2,2])
CL Item
Died (If patient died, STOP: go to SAE section and follow instructions given there.) (3)
Item
Event Course
integer
C0750729 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
CL Item
Intermittent (-> No. of episodes) (1)
Item
Intensity (maximum)
integer
C0518690 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
Code List
Intensity (maximum)
Item
Relationship to study procedures performed prior to randomization
integer
C1510821 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
Code List
Relationship to study procedures performed prior to randomization
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
Corrective Therapy
Item
Corrective Therapy
boolean
C0087111 (UMLS CUI [1])
C0441471 (UMLS CUI [2,1])
C1442488 (UMLS CUI [2,2])
Patient withdrawn due to event
Item
Was patient withdrawn due to this specific event?
boolean
C0422727 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])