Informações:
Falhas:
ID
17021
Descrição
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
Palavras-chave
Versões (2)
- 21/08/2016 21/08/2016 -
- 21/08/2016 21/08/2016 -
Transferido a
21 de agosto de 2016
DOI
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Licença
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
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
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
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
CL Item
Single Episode (Single Episode)
CL Item
Intermittent (Intermittent)
CL Item
Continuous (Continuous)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
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])
C1705104 (UMLS CUI [1,2])
CL Item
Dose Not Changed (1)
CL Item
Dose Reduced (2)
CL Item
Permanent Discontinuation (3)
CL Item
Not Applicable (4)
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])
C0013227 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
Item
Relationship to QUTENZA
integer
C1510821 (UMLS CUI [1])
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
Code List
Please confirm if the Adverse Event is an Application Site Reaction
CL Item
no (0)
CL Item
yes (1)