ID

28477

Beschreibung

Study part: 2 Meter Visual Acuity Day 0. A Phase III, Multicenter, Randomized, Double-Masked, Active Treatment-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne®) Photodynamic Therapy In Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration.

Stichworte

Versionen (1)
  1. 16.01.18 16.01.18 -
Rechteinhaber

Roche

Hochgeladen am

16. Januar 2018

DOI

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Creative Commons BY-NC 3.0
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2 Meter Visual Acuity Day 0 rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2587g

Englisch

2 Meter Visual Acuity Day 0

1 Formulare  
2 METER VISUAL ACUITY (SCREENING)
Beschreibung

2 METER VISUAL ACUITY (SCREENING)

Alias
UMLS CUI-1
C0042812
Subject Number:
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beschreibung

Subject Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Visit Date:
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Test Date:
Beschreibung

Test Date

Datentyp

date

Alias
UMLS CUI [1]
C2826247
RIGHT EYE
Beschreibung

RIGHT EYE

Alias
UMLS CUI-1
C0229089
Total Visual Acuity Score (ETDRS) Right eye- Not Done
Beschreibung

ETDRS visual acuity chart Right eye

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1275992
UMLS CUI [1,2]
C0229089
Total Visual Acuity Score (ETDRS) Right eye
Beschreibung

ETDRS visual acuity chart Right eye

Datentyp

text

Alias
UMLS CUI [1,1]
C1275992
UMLS CUI [1,2]
C0229089
Snellen Equivalent Right eye (most difficult line with 1 or no errors)
Beschreibung

Snellen Equivalent Right eye

Datentyp

text

Alias
UMLS CUI [1,1]
C1827708
UMLS CUI [1,2]
C0229089
Count Fingers?
Beschreibung

Do not complete if above total visual acuity score is > 0

Datentyp

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0449804
If Yes, provide maximum distance:
Beschreibung

Count Fingers

Datentyp

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0449804
Hand Movement?
Beschreibung

If Count Fingers is not measurable, please test

Datentyp

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0575809
If Yes:
Beschreibung

Hand Movement

Datentyp

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0575809
Light Perception?
Beschreibung

If Hand Movement is not measurable, please test

Datentyp

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C1154616
If Yes:
Beschreibung

Light Perception

Datentyp

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C1154616
LEFT EYE
Beschreibung

LEFT EYE

Alias
UMLS CUI-1
C0229090
Total Visual Acuity Score (ETDRS) Left eye- Not Done
Beschreibung

ETDRS visual acuity chart Left eye

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1275992
UMLS CUI [1,2]
C0229090
Total Visual Acuity Score (ETDRS) Left eye
Beschreibung

ETDRS visual acuity chart Left eye

Datentyp

text

Alias
UMLS CUI [1,1]
C1275992
UMLS CUI [1,2]
C0229090
Snellen Equivalent Left eye (most difficult line with 1 or no errors)
Beschreibung

Snellen Equivalent Left eye

Datentyp

text

Alias
UMLS CUI [1,1]
C1827708
UMLS CUI [1,2]
C0229090
Count Fingers?
Beschreibung

Do not complete if above total visual acuity score is > 0

Datentyp

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0449804
If Yes, provide maximum distance:
Beschreibung

Count Fingers

Datentyp

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0449804
Hand Movement?
Beschreibung

If Count Fingers is not measurable, please test

Datentyp

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0575809
If Yes:
Beschreibung

Hand Movement

Datentyp

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0575809
Light Perception?
Beschreibung

If Hand Movement is not measurable, please test

Datentyp

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C1154616
If Yes:
Beschreibung

Light Perception

Datentyp

text

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C1154616
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Ähnliche Modelle

2 Meter Visual Acuity Day 0

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
2 METER VISUAL ACUITY (SCREENING)
C0042812 (UMLS CUI-1)
Subject Number
Item
Subject Number:
text
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of visit
Item
Visit Date:
date
C1320303 (UMLS CUI [1])
Test Date
Item
Test Date:
date
C2826247 (UMLS CUI [1])
Item Group
RIGHT EYE
C0229089 (UMLS CUI-1)
ETDRS visual acuity chart Right eye
Item
Total Visual Acuity Score (ETDRS) Right eye- Not Done
boolean
C1275992 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
ETDRS visual acuity chart Right eye
Item
Total Visual Acuity Score (ETDRS) Right eye
text
C1275992 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Snellen Equivalent Right eye
Item
Snellen Equivalent Right eye (most difficult line with 1 or no errors)
text
C1827708 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Item
Count Fingers?
text
C0042793 (UMLS CUI [1,1])
C0449804 (UMLS CUI [1,2])
Count Fingers
Code List
Count Fingers?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done (Not Done)
Item
If Yes, provide maximum distance:
text
C0042793 (UMLS CUI [1,1])
C0449804 (UMLS CUI [1,2])
Count Fingers
Code List
If Yes, provide maximum distance:
CL Item
4 ft (4 ft)
CL Item
2 ft (2 ft)
CL Item
1 ft (1 ft)
Item
Hand Movement?
text
C0042793 (UMLS CUI [1,1])
C0575809 (UMLS CUI [1,2])
Count Fingers
Code List
Hand Movement?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done (Not Done)
Item
If Yes:
text
C0042793 (UMLS CUI [1,1])
C0575809 (UMLS CUI [1,2])
Hand Movement
Code List
If Yes:
CL Item
With Direction (With Direction)
CL Item
Without Direction (Without Direction)
Item
Light Perception?
text
C0042793 (UMLS CUI [1,1])
C1154616 (UMLS CUI [1,2])
Count Fingers
Code List
Light Perception?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done (Not Done)
Item
If Yes:
text
C0042793 (UMLS CUI [1,1])
C1154616 (UMLS CUI [1,2])
Light Perception
Code List
If Yes:
CL Item
With Projection (With Projection)
CL Item
Without Projection (Without Projection)
Item Group
LEFT EYE
C0229090 (UMLS CUI-1)
ETDRS visual acuity chart Left eye
Item
Total Visual Acuity Score (ETDRS) Left eye- Not Done
boolean
C1275992 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
ETDRS visual acuity chart Left eye
Item
Total Visual Acuity Score (ETDRS) Left eye
text
C1275992 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Snellen Equivalent Left eye
Item
Snellen Equivalent Left eye (most difficult line with 1 or no errors)
text
C1827708 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Item
Count Fingers?
text
C0042793 (UMLS CUI [1,1])
C0449804 (UMLS CUI [1,2])
Count Fingers
Code List
Count Fingers?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done (Not Done)
Item
If Yes, provide maximum distance:
text
C0042793 (UMLS CUI [1,1])
C0449804 (UMLS CUI [1,2])
Count Fingers
Code List
If Yes, provide maximum distance:
CL Item
4 ft (4 ft)
CL Item
2 ft (2 ft)
CL Item
1 ft (1 ft)
Item
Hand Movement?
text
C0042793 (UMLS CUI [1,1])
C0575809 (UMLS CUI [1,2])
Count Fingers
Code List
Hand Movement?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done (Not Done)
Item
If Yes:
text
C0042793 (UMLS CUI [1,1])
C0575809 (UMLS CUI [1,2])
Hand Movement
Code List
If Yes:
CL Item
With Direction (With Direction)
CL Item
Without Direction (Without Direction)
Item
Light Perception?
text
C0042793 (UMLS CUI [1,1])
C1154616 (UMLS CUI [1,2])
Count Fingers
Code List
Light Perception?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Done (Not Done)
Item
If Yes:
text
C0042793 (UMLS CUI [1,1])
C1154616 (UMLS CUI [1,2])
Light Perception
Code List
If Yes:
CL Item
With Projection (With Projection)
CL Item
Without Projection (Without Projection)
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