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22604

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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 #: 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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  1. 08/06/2017 08/06/2017 -
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Genentech, Inc.

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8 juin 2017

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Creative Commons BY-NC 3.0
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    VITAL SIGNS (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

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    VITAL SIGNS (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

    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
    VITAL SIGNS (SCREENING)
    Description

    VITAL SIGNS (SCREENING)

    Were any vital signs recorded at this visit?
    Description

    VITAL_SIGNS_RECORDS [VTLREC]

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1740486 (Vital signs (temperature, pulse, respiratory rate, and blood pressure) documented and reviewed (CAP) (EM))
    Vital Signs Date:
    Description

    VITAL_SIGNS_DT [VTLDT]

    Type de données

    date

    Unités de mesure
    • DD/MMM/YY
    Alias
    UMLS CUI [1,1]
    C2826644 (Vital Signs Date)
    DD/MMM/YY
    Vital Signs Time:
    Description

    VITAL_SIGNS_TIME [VTLTM]

    Type de données

    time

    Unités de mesure
    • 24 hr clock
    Alias
    UMLS CUI [1]
    C2827042 (Vital Signs Data Collection Date Time)
    24 hr clock
    Temp:
    Description

    TEMPERATURE [TEMP]

    Type de données

    float

    Unités de mesure
    • °C
    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    °C
    Pulse:
    Description

    PULSE [PULSE]

    Type de données

    integer

    Unités de mesure
    • /min
    Alias
    UMLS CUI [1]
    C0232117 (Pulse Rate)
    SNOMED
    78564009
    /min
    Resp:
    Description

    RESPIRATION [RESP]

    Type de données

    integer

    Unités de mesure
    • /min
    Alias
    UMLS CUI [1]
    C0231832 (Respiratory rate)
    SNOMED
    86290005
    LOINC
    LP20159-7
    /min
    Blood Pressure sys:
    Description

    BLOOD_PRESSURE_SYS [BPS]

    Type de données

    integer

    Unités de mesure
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Blood Pressure dys:
    Description

    BLOOD_PRESSURE_DIA [BPD]

    Type de données

    integer

    Unités de mesure
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Height:
    Description

    HEIGHT [HT]

    Type de données

    float

    Unités de mesure
    • cm
    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    cm
    Weight:
    Description

    WEIGHT [WT]

    Type de données

    float

    Unités de mesure
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Retour au début de la page

    Similar models

    VITAL SIGNS (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

    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
    VITAL SIGNS (SCREENING)
    VITAL_SIGNS_RECORDS [VTLREC]
    Item
    Were any vital signs recorded at this visit?
    boolean
    C1740486 (UMLS CUI [1,1])
    VITAL_SIGNS_DT [VTLDT]
    Item
    Vital Signs Date:
    date
    C2826644 (UMLS CUI [1,1])
    VITAL_SIGNS_TIME [VTLTM]
    Item
    Vital Signs Time:
    time
    C2827042 (UMLS CUI [1])
    TEMPERATURE [TEMP]
    Item
    Temp:
    float
    C0005903 (UMLS CUI [1])
    PULSE [PULSE]
    Item
    Pulse:
    integer
    C0232117 (UMLS CUI [1])
    RESPIRATION [RESP]
    Item
    Resp:
    integer
    C0231832 (UMLS CUI [1])
    BLOOD_PRESSURE_SYS [BPS]
    Item
    Blood Pressure sys:
    integer
    C0871470 (UMLS CUI [1])
    BLOOD_PRESSURE_DIA [BPD]
    Item
    Blood Pressure dys:
    integer
    C0428883 (UMLS CUI [1])
    HEIGHT [HT]
    Item
    Height:
    float
    C0005890 (UMLS CUI [1])
    WEIGHT [WT]
    Item
    Weight:
    float
    C0005910 (UMLS CUI [1])
    Retour au début de la page 

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