ID

17021

Description

Study Sponsor: Astellas Study Title Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study Medicine or Vaccine (generic name) capsaicin Sponsor Identification Number QTZ-EC-0002 Trial Registry Identification Number(#'s) NCT01416116 EudraCT Number: 2010-023258-34 Medical Condition Neuropathic pain Phase Phase 4 http://clinicaltrials.gov/show/NCT01416116 Cumulative Adverse Event 2

Link

http://clinicaltrials.gov/show/NCT01416116

Keywords

Versions (2)
  1. 8/21/16 8/21/16 -
  2. 8/21/16 8/21/16 -
Uploaded on

August 21, 2016

DOI

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License

Creative Commons BY 4.0
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Cumulative Form 1/3 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

English

Cumulative Form 1/3 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

1 forms  
Adverse Event 2
Description

Adverse Event 2

Adverse Event
Description

Adverse Event

Data type

text

Alias
UMLS CUI [1]
C0877248
Onset Date
Description

Onset Date

Data type

date

Alias
UMLS CUI [1]
C0574845
Onset Time
Description

Onset Time

Data type

time

Alias
UMLS CUI [1]
C0449244
If the onset date is unknown or the same day as pre-treatment, please select one.
Description

date is unknown

Data type

integer

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0439673
If the onset date is unknown or is the same day as application of Qutenza, please select one.
Description

onset date is unknown or same as application of Qutenza, please select one.

Data type

integer

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0439673
End Date
Description

End Date

Data type

date

Alias
UMLS CUI [1]
C0806020
End Time
Description

End Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
If 'Recovered with Sequelae is selected, please specify.
Description

Sequelae

Data type

text

Alias
UMLS CUI [1]
C0243088
Course of Event
Description

Course of Event

Data type

text

Alias
UMLS CUI [1]
C0750729
Severity
Description

Severity

Data type

integer

Alias
UMLS CUI [1]
C0439793
Serious AE
Description

If Seriousness is ‘yes’, tick all that apply

Data type

text

Alias
UMLS CUI [1]
C1519255
Number
Description

Number

Data type

integer

Alias
UMLS CUI [1]
C0449788
Death
Description

Death

Data type

boolean

Alias
UMLS CUI [1]
C0011065
Requires or prolongs hospitalization
Description

hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0019993
Congenital anomaly
Description

Congenital anomaly

Data type

boolean

Alias
UMLS CUI [1]
C2826727
Life-threatening
Description

Life-threatening

Data type

boolean

Alias
UMLS CUI [1]
C2826244
Persistent or significant disability/incapacity
Description

Persistent or significant disability/incapacity

Data type

boolean

Alias
UMLS CUI [1]
C0231170
Other Medical importance
Description

Other Medical importance

Data type

boolean

Alias
UMLS CUI [1,1]
C0205476
UMLS CUI [1,2]
C1705104
Action Taken for QUTENZA
Description

Action Taken

Data type

integer

Alias
UMLS CUI [1]
C2826626
Action Taken for Pretreatment
Description

Action Taken

Data type

integer

Alias
UMLS CUI [1]
C2826626
Treatment Required: None
Description

Treatment Required

Data type

boolean

Alias
UMLS CUI [1]
C2981656
Treatment Required: Drug Treatment
Description

Drug

Data type

text

Alias
UMLS CUI [1]
C0013227
Treatment Required: Non-Medication Therapy
Description

Non-Medication Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1518422
Relationship to QUTENZA
Description

Adverse Event Attribution to Product or Procedure

Data type

integer

Alias
UMLS CUI [1]
C1510821
Please confirm if the Adverse Event is an Application Site Reaction
Description

Application Site Reaction

Data type

integer

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Similar models

Cumulative Form 1/3 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Event 2
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])
date is unknown
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])
onset date is unknown or same as application of Qutenza, please select one.
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])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovering (2)
CL Item
Not Recovered (3)
CL Item
Recovered with Sequelae (4)
CL Item
Fatal (5)
CL Item
Unknown (6)
Sequelae
Item
If 'Recovered with Sequelae is selected, please specify.
text
C0243088 (UMLS CUI [1])
Item
Course of Event
text
C0750729 (UMLS CUI [1])
Course of Event
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])
Severity
Code List
Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Serious AE
text
C1519255 (UMLS CUI [1])
Serious AE
Code List
Serious AE
CL Item
no (0)
CL Item
yes (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])
Action Taken
Code List
Action Taken for QUTENZA
CL Item
Dose Not Changed (1)
CL Item
Dose Reduced (2)
CL Item
Permanent Discontinuation (3)
CL Item
Not Applicable (4)
Item
Action Taken for Pretreatment
integer
C2826626 (UMLS CUI [1])
Action Taken
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])
Adverse Event Attribution to Product or Procedure
Code List
Relationship to QUTENZA
CL Item
Not Related (1)
CL Item
Possible (2)
CL Item
Probable (3)
Item
Please confirm if the Adverse Event is an Application Site Reaction
integer
Application Site Reaction
Code List
Please confirm if the Adverse Event is an Application Site Reaction
CL Item
no (0)
CL Item
yes (1)
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