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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])
    Back to the top of the page 

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