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22741

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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 #: FVF4170g 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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Versions (1)
  1. 11/06/2017 11/06/2017 -
Détendeur de droits

Genentech, Inc.

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11 juin 2017

DOI

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Creative Commons BY-NC 3.0
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    CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12) CRFs Roche FVF4170G Macular Edema NCT00473382

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    CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12) CRFs Roche FVF4170G Macular Edema NCT00473382

    1 Formulaires  
    Patient administration
    Description

    Patient administration

    Subject Number
    Description

    PT

    Type de données

    integer

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

    PTINIT

    Type de données

    text

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

    VDT

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1302584 (Date of report)
    SNOMED
    399651003
    CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12)
    Description

    CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12)

    Were any medications taken?
    Description

    If Yes, record all medication beginning 7 days prior to Day 0. If indication for medication is an adverse event, complete appropriate Adverse Event CRF.

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0013216 (Pharmacotherapy)
    SNOMED
    416608005
    Medication
    Description

    Medication

    Line Number
    Description

    LINE_NUMBER [LN]

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0449788 (Count of entities)
    SNOMED
    410681005
    UMLS CUI [1,2]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    Medication
    Description

    MED_RAW_TERM [MDRAW]

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0013216 (Pharmacotherapy)
    SNOMED
    416608005
    Indication(s)
    Description

    MED_INDICATION [MDIND]

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013216 (Pharmacotherapy)
    SNOMED
    416608005
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Date Started
    Description

    START_DT [STRDT]

    Type de données

    date

    Unités de mesure
    • DD/MMM/YY
    Alias
    UMLS CUI [1]
    C0808070 (Start Date)
    DD/MMM/YY
    Date Stopped
    Description

    STOP_DT [STPDT]

    Type de données

    date

    Unités de mesure
    • DD/MMM/YY
    Alias
    UMLS CUI [1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    DD/MMM/YY
    Eye
    Description

    EYE [EYE]

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0015392 (Eye)
    SNOMED
    81745001
    LOINC
    LP7218-3
    Eye Code
    Description

    EYE_CODE [EYECD]

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0015392 (Eye)
    SNOMED
    81745001
    LOINC
    LP7218-3
    UMLS CUI [1,2]
    C0805701 (Code)
    Retour au début de la page

    Similar models

    CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12) CRFs Roche FVF4170G Macular Edema NCT00473382

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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
    CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12)
    MED_RECORDS [MDREC]
    Item
    Were any medications taken?
    boolean
    C0013216 (UMLS CUI [1])
    Item Group
    Medication
    LINE_NUMBER [LN]
    Item
    Line Number
    integer
    C0449788 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    MED_RAW_TERM [MDRAW]
    Item
    Medication
    text
    C0013216 (UMLS CUI [1])
    MED_INDICATION [MDIND]
    Item
    Indication(s)
    text
    C0013216 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    START_DT [STRDT]
    Item
    Date Started
    date
    C0808070 (UMLS CUI [1])
    STOP_DT [STPDT]
    Item
    Date Stopped
    date
    C0806020 (UMLS CUI [1])
    Item
    Eye
    integer
    C0015392 (UMLS CUI [1])
    LIGHT_PERCEPTION [LIPEC]
    Code List
    Eye
    CL Item
    NA (1)
    CL Item
    OD (2)
    CL Item
    OS (3)
    Item
    Eye Code
    integer
    C0015392 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    EYE_CODE [EYECD]
    Code List
    Eye Code
    CL Item
    Topical (1 )
    CL Item
    Subconjunctival (2 )
    CL Item
    Intracranial (anterior chamber) (3 )
    CL Item
    Intravitreal (4 )
    CL Item
    Posterior Subtenon’s (5 )
    CL Item
    Other (99 )
    Retour au début de la page 

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