ID

22607

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. 6/8/17 6/8/17 -
Copyright Holder

Genentech, Inc.

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June 8, 2017

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Creative Commons BY-NC 3.0
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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
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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)
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