Event
Item
Event (diagnosis only, otherwise sign/symptom)
text
C0877248 (UMLS CUI [1])
Modified term
Item
Modified term
text
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered with sequelae (4)
If "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date and Time
Item
If "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date and Time
text
C0806020 (UMLS CUI [1])
C1522314 (UMLS CUI [2])
If
Item
If "Fatal", record Date and Time of Death
text
C1148348 (UMLS CUI [1])
C1301931 (UMLS CUI [2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Not applicable (X)
Item
Actions taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1])
Code List
Actions taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Doce increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C3641099 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Does the Adverse Event meet the definition of serious?
text
C1710056 (UMLS CUI [1])
Code List
Does the Adverse Event meet the definition of serious?
Item
If "Yes", check all that apply
text
C1710056 (UMLS CUI [1])
Code List
If "Yes", check all that apply
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
If "Other", please specify
Item
If "Other", please specify
text
C2348235 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Item
Was SAE caused by an activity related to study participation (e.g., procedures)?
text
C1519255 (UMLS CUI [1,1])
C3641099 (UMLS CUI [1,2])
Code List
Was SAE caused by an activity related to study participation (e.g., procedures)?
Item
Clinical success
text
C0085565 (UMLS CUI [1])
Code List
Clinical success
Item
Clinical recurrence
text
C0679254 (UMLS CUI [1])
Code List
Clinical recurrence
Item
If "Yes", please specify if this was due to Primary or Secondary lesion:
text
C3640841 (UMLS CUI [1,1])
C1402294 (UMLS CUI [1,2])
C3640841 (UMLS CUI [2,1])
C1519215 (UMLS CUI [2,2])
Code List
If "Yes", please specify if this was due to Primary or Secondary lesion:
CL Item
Primary lesion (P)
CL Item
Secondary lesion (S)
Date of recurrence
Item
Date of recurrence
date
C0807712 (UMLS CUI [1])
Unable to determine clinical outcome, please specify:
Item
Unable to determine clinical outcome, please specify:
text
C0085565 (UMLS CUI [1,1])
C3845108 (UMLS CUI [1,2])