Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Onset Date
Item
Onset Date
date
C0574845 (UMLS CUI [1])
Onset Time
Item
Onset Time
time
C0449244 (UMLS CUI [1])
Item
If the onset date is unknown or the same day as pre-treatment, please select one.
integer
C0574845 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Code List
If the onset date is unknown or the same day as pre-treatment, please select one.
CL Item
Onset before Pre-treatment (1)
CL Item
Onset after start of (2)
CL Item
Pre-treatment (3)
Item
If the onset date is unknown or is the same day as application of Qutenza, please select one.
integer
C0574845 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Code List
If the onset date is unknown or is the same day as application of Qutenza, please select one.
CL Item
Onset before Application ofQutenza (1)
CL Item
Onset after start of Applicationof Qutenza (2)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Not Recovered (3)
CL Item
Recovered with Sequelae (4)
Sequelae
Item
If 'Recovered with Sequelae is selected, please specify.
text
C0243088 (UMLS CUI [1])
Item
Course of Event
text
C0750729 (UMLS CUI [1])
Code List
Course of Event
CL Item
Single Episode (Single Episode)
CL Item
Intermittent (Intermittent)
CL Item
Continuous (Continuous)
Item
Severity
integer
C0439793 (UMLS CUI [1])
Item
Serious AE
text
C1519255 (UMLS CUI [1])
Number
Item
Number
integer
C0449788 (UMLS CUI [1])
Death
Item
Death
boolean
C0011065 (UMLS CUI [1])
hospitalization
Item
Requires or prolongs hospitalization
boolean
C0019993 (UMLS CUI [1])
Congenital anomaly
Item
Congenital anomaly
boolean
C2826727 (UMLS CUI [1])
Life-threatening
Item
Life-threatening
boolean
C2826244 (UMLS CUI [1])
Persistent or significant disability/incapacity
Item
Persistent or significant disability/incapacity
boolean
C0231170 (UMLS CUI [1])
Other Medical importance
Item
Other Medical importance
boolean
C0205476 (UMLS CUI [1,1])
C1705104 (UMLS CUI [1,2])
Item
Action Taken for QUTENZA
integer
C2826626 (UMLS CUI [1])
Code List
Action Taken for QUTENZA
CL Item
Dose Not Changed (1)
CL Item
Permanent Discontinuation (3)
CL Item
Not Applicable (4)
Item
Action Taken for Pretreatment
integer
C2826626 (UMLS CUI [1])
Code List
Action Taken for Pretreatment
CL Item
Dose Not Changed (1)
CL Item
Permanent Discontinuation (2)
CL Item
Not Applicable (3)
Treatment Required
Item
Treatment Required: None
boolean
C2981656 (UMLS CUI [1])
Drug
Item
Treatment Required: Drug Treatment
text
C0013227 (UMLS CUI [1])
Non-Medication Therapy
Item
Treatment Required: Non-Medication Therapy
boolean
C0087111 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
Item
Relationship to QUTENZA
integer
C1510821 (UMLS CUI [1])
Code List
Relationship to QUTENZA
Item
Please confirm if the Adverse Event is an Application Site Reaction
integer
Code List
Please confirm if the Adverse Event is an Application Site Reaction