0 Evaluaciones
ID

23259

Descripción

Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

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Versiones (2)
  1. 28/6/17 28/6/17 -
  2. 1/7/17 1/7/17 -
Titular de derechos de autor

Genentech, Inc.

Subido en

1 de julio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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    STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)CRFs Roche FVF4168G Macular Edema NCT00473330

    Inglés

    STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)CRFs Roche FVF4168G Macular Edema NCT00473330

    1 formularios  
    Patient administration
    Descripción

    Patient administration

    Subject Number
    Descripción

    PT

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Subject Initials:
    Descripción

    PTINIT

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1997894 (Clinical trial participant (person))
    SNOMED
    428024001
    UMLS CUI [1,2]
    C2986440 (Person Initials)
    Report Date:
    Descripción

    VDT

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1302584 (Date of report)
    SNOMED
    399651003
    STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)
    Descripción

    STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)

    Indicate if the subject completed the study drug treatment or discontinued early (check one only):
    Descripción

    TX_DRUG_DISC [TXDISC]

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2826674 (Study Treatment Course Completion Occurrence)
    Date Subject Discontinued Study Drug Treatment Early:
    Descripción

    TX_DISCONTINUED_DT [TXDCDT]

    Tipo de datos

    date

    Unidades de medida
    • DD/MMM/YY
    Alias
    UMLS CUI [1,1]
    C0558681 (Medication discontinued)
    SNOMED
    274512008
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    DD/MMM/YY
    Check the PRIMARY reason the subject discontinued study drug treatment early
    Descripción

    TX_DRUG_DISC_REASON [TXREAS]

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0558681 (Medication discontinued)
    SNOMED
    274512008
    UMLS CUI [1,2]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    Please specify intervention:
    Descripción

    TX_DISC_REASON_SP [TXDCRS]

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0558681 (Medication discontinued)
    SNOMED
    274512008
    UMLS CUI [1,2]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,3]
    C0184661 (Interventional procedure)
    SNOMED
    71388002
    Volver a la parte superior de la página

    Similar models

    STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)CRFs Roche FVF4168G Macular Edema NCT00473330

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Patient administration
    PT
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    PTINIT
    Item
    Subject Initials:
    text
    C1997894 (UMLS CUI [1,1])
    C2986440 (UMLS CUI [1,2])
    VDT
    Item
    Report Date:
    date
    C1302584 (UMLS CUI [1,1])
    Item Group
    STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)
    Item
    Indicate if the subject completed the study drug treatment or discontinued early (check one only):
    integer
    C2826674 (UMLS CUI [1])
    TX_DRUG_DISC [TXDISC]
    Code List
    Indicate if the subject completed the study drug treatment or discontinued early (check one only):
    CL Item
    Subject Completed Study Drug Treatment (1)
    CL Item
    Subject Discontinued Study Drug Treatment Early (2)
    TX_DISCONTINUED_DT [TXDCDT]
    Item
    Date Subject Discontinued Study Drug Treatment Early:
    date
    C0558681 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Check the PRIMARY reason the subject discontinued study drug treatment early
    integer
    C0558681 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    TX_DRUG_DISC_REASON [TXREAS]
    Code List
    Check the PRIMARY reason the subject discontinued study drug treatment early
    CL Item
    Adverse Event (complete appropriate Adverse Event CRF) (1)
    CL Item
    Death (complete Study Completion / Early Discontinuation CRF) (2)
    CL Item
    Lost to follow-up (3)
    CL Item
    Physician’s decision to discontinue treatment (for reasons other than AE) (4)
    CL Item
    Subject’s decision to discontinue treatment (for reasons other than AE) (5)
    CL Item
    Sponsor’s decision to terminate study (6)
    CL Item
    Pregnancy (complete Pregnancy CRF) (7)
    CL Item
    Subject non-compliance (8)
    CL Item
    Subject’s condition mandated other therapeutic intervention (9)
    Item
    Please specify intervention:
    text
    C0558681 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0184661 (UMLS CUI [1,3])
    TX_DRUG_DISC_REASON [TXREAS]
    Code List
    Please specify intervention:
    Volver a la parte superior de la página 

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