0 Evaluaciones
ID

16544

Descripción

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 Screening Visit, Form 1/4: Date of Visit Screening Status Informed Consent 1 Demographics Medical and Surgical History

Link

http://clinicaltrials.gov/show/NCT01416116

Palabras clave

Versiones (2)
  1. 21/7/16 21/7/16 -
  2. 23/7/16 23/7/16 -
Subido en

23 de julio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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    Screening Visit Form 1/4 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

    Inglés

    Screening Visit Form 1/4 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 formularios  
    Date of Visit
    Descripción

    Date of Visit

    Date of Visit
    Descripción

    Field name: VDDT

    Tipo de datos

    date

    Screening Status
    Descripción

    Screening Status

    Is the subject a screen failure (signed an informed consent but was not randomized)?
    Descripción

    Field Name: DSYN

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1710476
    Reason for Not Meeting Admission Criteria
    Descripción

    Field Name: SFDECOD

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0030673
    UMLS CUI [1,2]
    C0392360
    If 'Other' specify
    Descripción

    Field Name: SFOTHSP

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0205394
    Informed Consent 1
    Descripción

    Informed Consent 1

    Date of Informed Consent
    Descripción

    DSSTDT

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985782
    Demographics
    Descripción

    Demographics

    Sex
    Descripción

    Sex

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0079399
    Birth Date
    Descripción

    Field Name: BRTHDT

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0421451
    Age
    Descripción

    Field Name: Age

    Tipo de datos

    integer

    Unidades de medida
    • Years
    Alias
    UMLS CUI [1]
    C0001779
    Years
    Race
    Descripción

    Field Name :RACE

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0034510
    If 'Other', specify
    Descripción

    Field Name: RACEOTH

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0034510
    Medical and Surgical History
    Descripción

    Medical and Surgical History

    Is there any past or present Medical Condition? If 'Yes', please provide details below
    Descripción

    Field Name: MHANY

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0012634
    MedicalCondition, specify
    Descripción

    Field Name: MHTERM

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0012634
    Onset Date
    Descripción

    Field Name: MHSTDT

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0574845
    Is Medical Condition ongoing? If 'No', please provide 'Recovered Date'.
    Descripción

    Field Name: MHONGO

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0549178
    UMLS CUI [1,2]
    C0012634
    Recovered Date
    Descripción

    Field Name: MHENDT

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0237820
    UMLS CUI [1,2]
    C0011008
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    Screening Visit Form 1/4 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 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Date of Visit
    Date of Visit
    Item
    Date of Visit
    date
    Item Group
    Screening Status
    Item
    Is the subject a screen failure (signed an informed consent but was not randomized)?
    integer
    C1710476 (UMLS CUI [1])
    Screen failure
    Code List
    Is the subject a screen failure (signed an informed consent but was not randomized)?
    CL Item
    No (0)
    CL Item
    Yes (1)
    Item
    Reason for Not Meeting Admission Criteria
    integer
    C0030673 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    no admission, reason
    Code List
    Reason for Not Meeting Admission Criteria
    CL Item
    Not fulfill inclusion or exclusion criteria (1 )
    CL Item
    Untoward Medical Symptoms (3 )
    CL Item
    Subject lost to follow up (7 )
    CL Item
    Other (99 )
    CL Item
    Withdrawal of consent (6 )
    Other
    Item
    If 'Other' specify
    text
    C0205394 (UMLS CUI [1])
    Item Group
    Informed Consent 1
    Date of Informed Consent
    Item
    Date of Informed Consent
    date
    C2985782 (UMLS CUI [1])
    Item Group
    Demographics
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Sex
    Code List
    Sex
    CL Item
    Male (1)
    CL Item
    Female (2)
    Birth Date
    Item
    Birth Date
    date
    C0421451 (UMLS CUI [1])
    Age
    Item
    Age
    integer
    C0001779 (UMLS CUI [1])
    Item
    Race
    integer
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    White (1 )
    CL Item
    Black or African American (3 )
    CL Item
    Asian (4 )
    CL Item
    American Indian or Alaskan Native (5 )
    CL Item
    Native Hawaiian or Other Pacific Islander (6 )
    CL Item
    Other (99 )
    Other race
    Item
    If 'Other', specify
    text
    C0205394 (UMLS CUI [1,1])
    C0034510 (UMLS CUI [1,2])
    Item Group
    Medical and Surgical History
    Item
    Is there any past or present Medical Condition? If 'Yes', please provide details below
    integer
    C0012634 (UMLS CUI [1])
    medical condition
    Code List
    Is there any past or present Medical Condition? If 'Yes', please provide details below
    CL Item
    No (0 )
    CL Item
    Yes (1 )
    Medical Condition
    Item
    MedicalCondition, specify
    text
    C0012634 (UMLS CUI [1])
    Onset Date
    Item
    Onset Date
    date
    C0574845 (UMLS CUI [1])
    Item
    Is Medical Condition ongoing? If 'No', please provide 'Recovered Date'.
    integer
    C0549178 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    ongoing
    Code List
    Is Medical Condition ongoing? If 'No', please provide 'Recovered Date'.
    CL Item
    No (0 )
    CL Item
    Yes (1 )
    date of recovery
    Item
    Recovered Date
    date
    C0237820 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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