ID

22608

Beschreibung

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

Stichworte

Versionen (1)
  1. 08.06.17 08.06.17 -
Rechteinhaber

Genentech, Inc.

Hochgeladen am

8. Juni 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

  • Neueste
  • Älteste
  • Beliebt
  • Neueste
    • Neueste
    • Älteste
    • Beliebt

Keine Kommentare

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

4 METER VISUAL ACUITY / LEFT EYE CHART 2 (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

Englisch

4 METER VISUAL ACUITY / LEFT EYE CHART 2 (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulare  
Patient administration
Beschreibung

Patient administration

Subject Number
Beschreibung

PT

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beschreibung

PTINIT

Datentyp

text

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

VDT

Datentyp

date

Alias
UMLS CUI [1,1]
C1302584
4 METER VISUAL ACUITY / LEFT EYE CHART 2 (SCREENING) CONTINUED
Beschreibung

4 METER VISUAL ACUITY / LEFT EYE CHART 2 (SCREENING) CONTINUED

Test Date:
Beschreibung

EXAM_DT [EXMDT]

Datentyp

date

Maßeinheiten
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0200150
UMLS CUI [1,2]
C0229090
UMLS CUI [1,3]
C0011008
DD/MMM/YY
Examiner Name (print):
Beschreibung

RATER_NAME [RATNM]

Datentyp

text

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

SECTION I = 4 Meter Test

Number correct at 4 meters, Chart 1 Letters D S R K N
Beschreibung

Row 1, Snellen Equivalent 20/200

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 4 meters, Chart 1 Letters C K Z O H
Beschreibung

Row 1, Snellen Equivalent 20/160

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 4 meters, Chart 1 Letters O N R K D
Beschreibung

Row 1, Snellen Equivalent 20/125

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 4 meters, Chart 1 Letters K Z V D C
Beschreibung

Row 1, Snellen Equivalent 20/100

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 4 meters, Chart 1 Letters V S H Z O
Beschreibung

Row 1, Snellen Equivalent 20/80

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 4 meters, Chart 1 Letters H D K C R
Beschreibung

Row 1, Snellen Equivalent 20/63

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 4 meters, Chart 1 Letters C S R H N
Beschreibung

Row 1, Snellen Equivalent 20/50

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 4 meters, Chart 1 Letters S V Z D K
Beschreibung

Row 1, Snellen Equivalent 20/40

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 4 meters, Chart 1 Letters N C V O Z
Beschreibung

Row 1, Snellen Equivalent 20/32

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 4 meters, Chart 1 Letters R H S D V
Beschreibung

Row 1, Snellen Equivalent 20/25

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 4 meters, Chart 1 Letters S N R O H
Beschreibung

Row 1, Snellen Equivalent 20/20

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 4 meters, Chart 1 Letters O D H K R
Beschreibung

Row 1, Snellen Equivalent 20/16

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 4 meters, Chart 1 Letters Z K C S N
Beschreibung

Row 1, Snellen Equivalent 20/12.5

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 4 meters, Chart 1 Letters C R H D V
Beschreibung

Row 1, Snellen Equivalent 20/10

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Total number correct at 4 meters
Beschreibung

SCORE [SCORE1]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
SECTION II = 1 Meter Test
Beschreibung

SECTION II = 1 Meter Test

Number correct at 1 meter, Chart 1 Letters D S R K N
Beschreibung

Row 1, Snellen Equivalent 20/800

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 1 meter, Chart 1 Letters C K Z O H
Beschreibung

Row 2, Snellen Equivalent 20/640

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 1 meter, Chart 1 Letters O N R K D
Beschreibung

Row 3, Snellen Equivalent 20/500

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 1 meter, Chart 1 Letters K Z V D C
Beschreibung

Row 4, Snellen Equivalent 20/400

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 1 meter, Chart 1 Letters V S H Z O
Beschreibung

Row 5, Snellen Equivalent 20/320

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Number correct at 1 meter, Chart 1 Letters H D K C R
Beschreibung

Row 6, Snellen Equivalent 20/250

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Total number correct at 1 meter
Beschreibung

SCORE [SCORE2]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
SECTION III = Computing VA Score & Snellen Equivalent
Beschreibung

SECTION III = Computing VA Score & Snellen Equivalent

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

SEGMENT_NUMBER [SEGNO1]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
B. If A >=4, write 30; otherwise, write zero
Beschreibung

SEGMENT_NUMBER [SEGNO2]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
C. Total correct at 1 meter (SECTION II) (If not tested, write zero)
Beschreibung

SEGMENT_NUMBER [SEGNO3]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
A + B + C =
Beschreibung

SCORE [SCORE3]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
SNELLEN EQUIVALENT Left Eye 20/_ _ _
Beschreibung

SNELLEN_VALUE [SNLVAL]

Datentyp

integer

Alias
UMLS CUI [1,1]
C1827708
UMLS CUI [1,2]
C0229090
(Most difficult line with 1 or no errors) OR Snellen Equivalent worse than 20/800
Beschreibung

SNELLEN_WORSE [SNLWRS]

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1827708
UMLS CUI [1,2]
C0229090
SECTION IV = Low Vision Testing
Beschreibung

SECTION IV = Low Vision Testing

Count fingers?
Beschreibung

COUNT_FINGERS [CTFGR]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0229090
UMLS CUI [1,3]
C0449804
If Yes, maximum distance:
Beschreibung

MAXIMUM_DISTANCE [MAXDST]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442747
UMLS CUI [1,2]
C0042793
UMLS CUI [1,3]
C0229090
Hand movement?
Beschreibung

HAND_MOVEMENT [HDMVT]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0229090
UMLS CUI [1,3]
C0575809
If Yes:
Beschreibung

HAND_MOVEMENT_DESC [HDMVTD]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0575809
UMLS CUI [1,2]
C0229090
Light Perception?
Beschreibung

LIGHT_PERCEPTION [LIPEC]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0229090
UMLS CUI [1,3]
C1154616
If Yes:
Beschreibung

LIGHT_PERCEPTION_DES [LIPECD]

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442772
UMLS CUI [1,2]
C0229090
Zum Seitenanfang zurückkehren

Ähnliche Modelle

4 METER VISUAL ACUITY / LEFT EYE CHART 2 (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 / LEFT EYE CHART 2 (SCREENING) CONTINUED
EXAM_DT [EXMDT]
Item
Test Date:
date
C0200150 (UMLS CUI [1,1])
C0229090 (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 D S R K N
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD2]
Item
Number correct at 4 meters, Chart 1 Letters C K Z O H
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD3]
Item
Number correct at 4 meters, Chart 1 Letters O N R K D
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD4]
Item
Number correct at 4 meters, Chart 1 Letters K Z V D C
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD5]
Item
Number correct at 4 meters, Chart 1 Letters V S H Z O
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD6]
Item
Number correct at 4 meters, Chart 1 Letters H D K C R
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD7]
Item
Number correct at 4 meters, Chart 1 Letters C S R H N
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD8]
Item
Number correct at 4 meters, Chart 1 Letters S V Z D K
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD9]
Item
Number correct at 4 meters, Chart 1 Letters N C V O Z
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD10]
Item
Number correct at 4 meters, Chart 1 Letters R H S D V
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD11]
Item
Number correct at 4 meters, Chart 1 Letters S N R O H
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD12]
Item
Number correct at 4 meters, Chart 1 Letters O D H K R
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD13]
Item
Number correct at 4 meters, Chart 1 Letters Z K C S N
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD14]
Item
Number correct at 4 meters, Chart 1 Letters C R H D V
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
SCORE [SCORE1]
Item
Total number correct at 4 meters
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Item Group
SECTION II = 1 Meter Test
CORRECT_READING [COTRD15]
Item
Number correct at 1 meter, Chart 1 Letters D S R K N
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD16]
Item
Number correct at 1 meter, Chart 1 Letters C K Z O H
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD17]
Item
Number correct at 1 meter, Chart 1 Letters O N R K D
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD18]
Item
Number correct at 1 meter, Chart 1 Letters K Z V D C
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD19]
Item
Number correct at 1 meter, Chart 1 Letters V S H Z O
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD20]
Item
Number correct at 1 meter, Chart 1 Letters H D K C R
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
SCORE [SCORE2]
Item
Total number correct at 1 meter
integer
C0442746 (UMLS CUI [1,1])
C0229090 (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])
C0229090 (UMLS CUI [1,2])
Item
B. If A >=4, write 30; otherwise, write zero
integer
C0442746 (UMLS CUI [1,1])
C0229090 (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])
C0229090 (UMLS CUI [1,2])
SCORE [SCORE3]
Item
A + B + C =
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
SNELLEN_VALUE [SNLVAL]
Item
SNELLEN EQUIVALENT Left Eye 20/_ _ _
integer
C1827708 (UMLS CUI [1,1])
C0229090 (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])
C0229090 (UMLS CUI [1,2])
Item Group
SECTION IV = Low Vision Testing
Item
Count fingers?
integer
C0042793 (UMLS CUI [1,1])
C0229090 (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])
C0229090 (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])
C0229090 (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])
C0229090 (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])
C0229090 (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])
C0229090 (UMLS CUI [1,2])
LIGHT_PERCEPTION [LIPEC]
Code List
If Yes:
CL Item
With Projection (1)
CL Item
Without Projection (2)
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video