0 Ratings
ID

22740

Description

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

Keywords

Versions (1)
  1. 6/11/17 6/11/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

June 11, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12) CRFs Roche FVF4168G Macular Edema NCT00473330

    English

    CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12) CRFs Roche FVF4168G Macular Edema NCT00473330

    1 forms  
    Patient administration
    Description

    Patient administration

    Subject Number
    Description

    PT

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials:
    Description

    PTINIT

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1997894
    UMLS CUI [1,2]
    C2986440
    Report Date:
    Description

    VDT

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302584
    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.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013216
    Medication
    Description

    Medication

    Line Number
    Description

    LINE_NUMBER [LN]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0449788
    UMLS CUI [1,2]
    C0087111
    Medication
    Description

    MED_RAW_TERM [MDRAW]

    Data type

    text

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

    MED_INDICATION [MDIND]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0392360
    Date Started
    Description

    START_DT [STRDT]

    Data type

    date

    Measurement units
    • DD/MMM/YY
    Alias
    UMLS CUI [1]
    C0808070
    DD/MMM/YY
    Date Stopped
    Description

    STOP_DT [STPDT]

    Data type

    date

    Measurement units
    • DD/MMM/YY
    Alias
    UMLS CUI [1]
    C0806020
    DD/MMM/YY
    Eye
    Description

    EYE [EYE]

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015392
    Eye Code
    Description

    EYE_CODE [EYECD]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0015392
    UMLS CUI [1,2]
    C0805701
    Back to the top of the page

    Similar models

    CONCOMITANT MEDICATIONS (DAY 0 - MONTH 12) CRFs Roche FVF4168G Macular Edema NCT00473330

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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 )
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial