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22607

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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. 6/8/17 6/8/17 -
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Genentech, Inc.

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June 8, 2017

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    4 METER VISUAL ACUITY / RIGHT EYE CHART 1 (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

    English

    4 METER VISUAL ACUITY / RIGHT EYE CHART 1 (SCREENING) 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
    4 METER VISUAL ACUITY / RIGHT EYE CHART 1 (SCREENING)
    Description

    4 METER VISUAL ACUITY / RIGHT EYE CHART 1 (SCREENING)

    Test Date:
    Description

    EXAM_DT [EXMDT]

    Data type

    date

    Measurement units
    • DD/MMM/YY
    Alias
    UMLS CUI [1,1]
    C0200150
    UMLS CUI [1,2]
    C0229089
    UMLS CUI [1,3]
    C0011008
    DD/MMM/YY
    Examiner Name (print):
    Description

    RATER_NAME [RATNM]

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    SECTION I = 4 Meter Test
    Description

    SECTION I = 4 Meter Test

    Number correct at 4 meters, Chart 1 Letters N C K Z O
    Description

    Row 1, Snellen Equivalent 20/200

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 4 meters, Chart 1 Letters R H S D K
    Description

    Row 1, Snellen Equivalent 20/160

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 4 meters, Chart 1 Letters D O V H R
    Description

    Row 1, Snellen Equivalent 20/125

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 4 meters, Chart 1 Letters C Z R H S
    Description

    Row 1, Snellen Equivalent 20/100

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 4 meters, Chart 1 Letters O N H R C
    Description

    Row 1, Snellen Equivalent 20/80

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 4 meters, Chart 1 Letters D K S N V
    Description

    Row 1, Snellen Equivalent 20/63

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 4 meters, Chart 1 Letters Z S O K N
    Description

    Row 1, Snellen Equivalent 20/50

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 4 meters, Chart 1 Letters C K D N R
    Description

    Row 1, Snellen Equivalent 20/40

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 4 meters, Chart 1 Letters S R Z K D
    Description

    Row 1, Snellen Equivalent 20/32

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 4 meters, Chart 1 Letters H Z O V C
    Description

    Row 1, Snellen Equivalent 20/25

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 4 meters, Chart 1 Letters N V D O K
    Description

    Row 1, Snellen Equivalent 20/20

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 4 meters, Chart 1 Letters V H C N O
    Description

    Row 1, Snellen Equivalent 20/16

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 4 meters, Chart 1 Letters S V H C Z
    Description

    Row 1, Snellen Equivalent 20/12.5

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 4 meters, Chart 1 Letters O Z D V K
    Description

    Row 1, Snellen Equivalent 20/10

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Total number correct at 4 meters
    Description

    SCORE [SCORE1]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    SECTION II = 1 Meter Test
    Description

    SECTION II = 1 Meter Test

    Number correct at 1 meter, Chart 1 Letters N C K Z O
    Description

    Row 1, Snellen Equivalent 20/800

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 1 meter, Chart 1 Letters R H S D K
    Description

    Row 2, Snellen Equivalent 20/640

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 1 meter, Chart 1 Letters D O V H R
    Description

    Row 3, Snellen Equivalent 20/500

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 1 meter, Chart 1 Letters C Z R H S
    Description

    Row 4, Snellen Equivalent 20/400

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 1 meter, Chart 1 Letters O N H R C
    Description

    Row 5, Snellen Equivalent 20/320

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Number correct at 1 meter, Chart 1 Letters D K S N V
    Description

    Row 6, Snellen Equivalent 20/250

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    Total number correct at 1 meter
    Description

    SCORE [SCORE2]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    SECTION III = Computing VA Score & Snellen Equivalent
    Description

    SECTION III = Computing VA Score & Snellen Equivalent

    A. Total number correct at 4 meters: (SECTION I)
    Description

    SEGMENT_NUMBER [SEGNO1]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    B. If A >=4, write 30; otherwise, write zero
    Description

    SEGMENT_NUMBER [SEGNO2]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    C. Total correct at 1 meter (SECTION II) (If not tested, write zero)
    Description

    SEGMENT_NUMBER [SEGNO3]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    A + B + C =
    Description

    SCORE [SCORE3]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442746
    UMLS CUI [1,2]
    C0229089
    SNELLEN EQUIVALENT Right Eye 20/_ _ _
    Description

    SNELLEN_VALUE [SNLVAL]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1827708
    UMLS CUI [1,2]
    C0229089
    (Most difficult line with 1 or no errors) OR Snellen Equivalent worse than 20/800
    Description

    SNELLEN_WORSE [SNLWRS]

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1827708
    UMLS CUI [1,2]
    C0229089
    SECTION IV = Low Vision Testing
    Description

    SECTION IV = Low Vision Testing

    Count fingers?
    Description

    COUNT_FINGERS [CTFGR]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0042793
    UMLS CUI [1,2]
    C0229089
    UMLS CUI [1,3]
    C0449804
    If Yes, maximum distance:
    Description

    MAXIMUM_DISTANCE [MAXDST]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442747
    UMLS CUI [1,2]
    C0042793
    UMLS CUI [1,3]
    C0229089
    Hand movement?
    Description

    HAND_MOVEMENT [HDMVT]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0042793
    UMLS CUI [1,2]
    C0229089
    UMLS CUI [1,3]
    C0575809
    If Yes:
    Description

    HAND_MOVEMENT_DESC [HDMVTD]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0575809
    UMLS CUI [1,2]
    C0229089
    Light Perception?
    Description

    LIGHT_PERCEPTION [LIPEC]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0042793
    UMLS CUI [1,2]
    C0229089
    UMLS CUI [1,3]
    C1154616
    If Yes:
    Description

    LIGHT_PERCEPTION_DES [LIPECD]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442772
    UMLS CUI [1,2]
    C0229089
    Back to the top of the page

    Similar models

    4 METER VISUAL ACUITY / RIGHT EYE CHART 1 (SCREENING) 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
    4 METER VISUAL ACUITY / RIGHT EYE CHART 1 (SCREENING)
    EXAM_DT [EXMDT]
    Item
    Test Date:
    date
    C0200150 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    RATER_NAME [RATNM]
    Item
    Examiner Name (print):
    text
    C2826892 (UMLS CUI [1])
    Item Group
    SECTION I = 4 Meter Test
    CORRECT_READING [COTRD1]
    Item
    Number correct at 4 meters, Chart 1 Letters N C K Z O
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD2]
    Item
    Number correct at 4 meters, Chart 1 Letters R H S D K
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD3]
    Item
    Number correct at 4 meters, Chart 1 Letters D O V H R
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD4]
    Item
    Number correct at 4 meters, Chart 1 Letters C Z R H S
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD5]
    Item
    Number correct at 4 meters, Chart 1 Letters O N H R C
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD6]
    Item
    Number correct at 4 meters, Chart 1 Letters D K S N V
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD7]
    Item
    Number correct at 4 meters, Chart 1 Letters Z S O K N
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD8]
    Item
    Number correct at 4 meters, Chart 1 Letters C K D N R
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD9]
    Item
    Number correct at 4 meters, Chart 1 Letters S R Z K D
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD10]
    Item
    Number correct at 4 meters, Chart 1 Letters H Z O V C
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD11]
    Item
    Number correct at 4 meters, Chart 1 Letters N V D O K
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD12]
    Item
    Number correct at 4 meters, Chart 1 Letters V H C N O
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD13]
    Item
    Number correct at 4 meters, Chart 1 Letters S V H C Z
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD14]
    Item
    Number correct at 4 meters, Chart 1 Letters O Z D V K
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    SCORE [SCORE1]
    Item
    Total number correct at 4 meters
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Item Group
    SECTION II = 1 Meter Test
    CORRECT_READING [COTRD15]
    Item
    Number correct at 1 meter, Chart 1 Letters N C K Z O
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD16]
    Item
    Number correct at 1 meter, Chart 1 Letters R H S D K
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD17]
    Item
    Number correct at 1 meter, Chart 1 Letters D O V H R
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD18]
    Item
    Number correct at 1 meter, Chart 1 Letters C Z R H S
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD19]
    Item
    Number correct at 1 meter, Chart 1 Letters O N H R C
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD20]
    Item
    Number correct at 1 meter, Chart 1 Letters D K S N V
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    SCORE [SCORE2]
    Item
    Total number correct at 1 meter
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Item Group
    SECTION III = Computing VA Score & Snellen Equivalent
    SEGMENT_NUMBER [SEGNO1]
    Item
    A. Total number correct at 4 meters: (SECTION I)
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Item
    B. If A >=4, write 30; otherwise, write zero
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    SLIT_LAMP_AQ_CELL [SLAQC]
    Code List
    B. If A >=4, write 30; otherwise, write zero
    CL Item
    N/A (1)
    CL Item
    0 (2)
    CL Item
    Trace (3)
    CL Item
    1+ (4)
    CL Item
    2+ (5)
    CL Item
    3+ (6)
    CL Item
    4+ (7)
    SEGMENT_NUMBER [SEGNO3]
    Item
    C. Total correct at 1 meter (SECTION II) (If not tested, write zero)
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    SCORE [SCORE3]
    Item
    A + B + C =
    integer
    C0442746 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    SNELLEN_VALUE [SNLVAL]
    Item
    SNELLEN EQUIVALENT Right Eye 20/_ _ _
    integer
    C1827708 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    SNELLEN_WORSE [SNLWRS]
    Item
    (Most difficult line with 1 or no errors) OR Snellen Equivalent worse than 20/800
    boolean
    C1827708 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    Item Group
    SECTION IV = Low Vision Testing
    Item
    Count fingers?
    integer
    C0042793 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    C0449804 (UMLS CUI [1,3])
    COUNT_FINGERS [CTFGR]
    Code List
    Count fingers?
    CL Item
    Yes (1)
    CL Item
    No  (2)
    CL Item
    Not Done (3)
    Item
    If Yes, maximum distance:
    integer
    C0442747 (UMLS CUI [1,1])
    C0042793 (UMLS CUI [1,2])
    C0229089 (UMLS CUI [1,3])
    MAXIMUM_DISTANCE [MAXDST]
    Code List
    If Yes, maximum distance:
    CL Item
    4 ft (1)
    CL Item
    2 ft (2)
    CL Item
    1 ft (3)
    Item
    Hand movement?
    integer
    C0042793 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    C0575809 (UMLS CUI [1,3])
    COUNT_FINGERS [CTFGR]
    Code List
    Hand movement?
    CL Item
    Yes (1)
    CL Item
    No  (2)
    CL Item
    Not Done (3)
    Item
    If Yes:
    integer
    C0575809 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    HAND_MOVEMENT_DESC [HDMVTD]
    Code List
    If Yes:
    CL Item
    With Direction (1)
    CL Item
    Without Direction (2)
    Item
    Light Perception?
    integer
    C0042793 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    C1154616 (UMLS CUI [1,3])
    COUNT_FINGERS [CTFGR]
    Code List
    Light Perception?
    CL Item
    Yes (1)
    CL Item
    No  (2)
    CL Item
    Not Done (3)
    Item
    If Yes:
    integer
    C0442772 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    LIGHT_PERCEPTION [LIPEC]
    Code List
    If Yes:
    CL Item
    With Projection (1)
    CL Item
    Without Projection (2)
    Back to the top of the page 

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