Patient ID; Centre Number
Item
Patient ID, Centre No.
text
C1269815 (UMLS CUI [1,1])
C2825181 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,3])
Patient ID; Envelope Number
Item
Patient ID, Envelope No.
text
C1269815 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Adverse event
Item
Advere Event
text
C0877248 (UMLS CUI [1])
Adverse event; Date of onset
Item
Date of Onset of Adverse Event (1st symptom)
date
C2985916 (UMLS CUI [1])
Adverse event; start time
Item
Time of Onset of Adverse Event (1st symptom)
time
C2697889 (UMLS CUI [1])
Item
Maximum Intensity
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Moderate (Moderate)
Adverse event; Relationship; study drug
Item
Is there a reasonable possibility that the AE was caused by the study drug?
boolean
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Adverse event; Relationship; study drug; action taken
Item
Was study drug stopped due to this event?
boolean
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C2826626 (UMLS CUI [1,4])
Adverse event; Relationship; study drug; corrective therapies
Item
Corrective Therapies
boolean
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0719519 (UMLS CUI [1,5])
Item
Outcome of AE
text
C1705586 (UMLS CUI [1])
CL Item
Recovered without sequelae (give date of recovery) (Recovered without sequelae (give date of recovery))
CL Item
Recovered with sequelae (specify sequelae) (Recovered with sequelae (specify sequelae))
CL Item
Recovering (Recovering)
CL Item
Not recovered (Not recovered)
CL Item
Unknown (Unknown)
Adverse event; seriousness criteria
Item
Seriousness Criteria
boolean
C1710056 (UMLS CUI [1])
Adverse event; seriousness; date
Item
Date when event became serious
date
C1710056 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Adverse event; seriousness; time
Item
Time when event became serious
time
C1710056 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Seriousness criteria
text
C1710056 (UMLS CUI [1])
Code List
Seriousness criteria
CL Item
Resulting in death (Resulting in death)
CL Item
Life threatening (Life threatening)
CL Item
Requiring or prolonging in-patient hospitalization (Requiring or prolonging in-patient hospitalization)
CL Item
Persistent or significant disability or incapacity (Persistent or significant disability or incapacity)
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
CL Item
Other (specify) (Other (specify))
Adverse event; significan bleeding
Item
Clinically significant bleeding
boolean
C1301880 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])