ID

42975

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 Unscheduled Visit >> Unscheduled Event Form Pregnancy Test Unscheduled Event

Link

http://clinicaltrials.gov/show/NCT01416116

Keywords

Versions (3)
  1. 8/21/16 8/21/16 -
  2. 8/21/16 8/21/16 -
  3. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Unscheduled Visit >> Unscheduled Event Form 2/2 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

Unscheduled Visit >> Unscheduled Event Form 2/2 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  
Pregnancy Test
Description

Pregnancy Test

Is subject female and of childbearing potential?
Description

If 'childbearing potential-NO', please provide reason of childbearing potential NO. If 'childbearing potential-YES', please provide details of pregnancy test below.

Data type

integer

Alias
UMLS CUI [1]
C0086287
UMLS CUI [2]
C3831118
Reason Childbearing potential - NO
Description

Reason Childbearing potential - NO

Data type

integer

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0392360
If 'Other', specify
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Select 'Not Done' if serum/urine sample was not taken.
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0457208
Date of Sample Taken
Description

Date of Sample Taken

Data type

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Result serum/urine pregnancy test
Description

Result serum/urine pregnancy test

Data type

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Unscheduled Event
Description

Unscheduled Event

Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Physical Examination
Description

Physical Examination

Data type

text

Alias
UMLS CUI [1]
C0031809
Vital signs
Description

Vital signs

Data type

text

Alias
UMLS CUI [1]
C0518766
ECG: 12 Lead ECG
Description

ECG: 12 Lead ECG

Data type

text

Alias
UMLS CUI [1]
C0013798
Hematology
Description

Hematology

Data type

text

Alias
UMLS CUI [1]
C0474523
Biochemistry
Description

Biochemistry

Data type

text

Alias
UMLS CUI [1]
C0005477
Pregnancy Test
Description

Pregnancy Test

Data type

text

Alias
UMLS CUI [1]
C0032976
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Similar models

Unscheduled Visit >> Unscheduled Event Form 2/2 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
Pregnancy Test
Item
Is subject female and of childbearing potential?
integer
C0086287 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
female childbearing potential
Code List
Is subject female and of childbearing potential?
CL Item
No (0)
CL Item
Yes (1)
Item
Reason Childbearing potential - NO
integer
C3831118 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason Childbearing potential - NO
Code List
Reason Childbearing potential - NO
CL Item
Female (2 yrs post-menopausal or surgically sterile) (1)
CL Item
Other (2)
Other
Item
If 'Other', specify
text
C0205394 (UMLS CUI [1])
Sample taken
Item
Select 'Not Done' if serum/urine sample was not taken.
boolean
C0457208 (UMLS CUI [1])
Date of Sample Taken
Item
Date of Sample Taken
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result serum/urine pregnancy test
integer
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result serum/urine pregnancy test
Code List
Result serum/urine pregnancy test
CL Item
Negative (0)
CL Item
Positive (1)
Item Group
Unscheduled Event
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Physical Examination
Item
Physical Examination
text
C0031809 (UMLS CUI [1])
Vital signs
Item
Vital signs
text
C0518766 (UMLS CUI [1])
ECG: 12 Lead ECG
Item
ECG: 12 Lead ECG
text
C0013798 (UMLS CUI [1])
Hematology
Item
Hematology
text
C0474523 (UMLS CUI [1])
Biochemistry
Item
Biochemistry
text
C0005477 (UMLS CUI [1])
Pregnancy Test
Item
Pregnancy Test
text
C0032976 (UMLS CUI [1])
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