ID

22730

Beschrijving

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. 11-06-17 11-06-17 -
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Genentech, Inc.

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Creative Commons BY-NC 3.0
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SLITLAMP EXAMINATION (DAY 7) CRFs Roche FVF4168G Macular Edema NCT00473330

Engels

SLITLAMP EXAMINATION (DAY 7) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulieren  
Patient administration
Beschrijving

Patient administration

Subject Number
Beschrijving

PT

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beschrijving

PTINIT

Datatype

text

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

VDT

Datatype

date

Alias
UMLS CUI [1,1]
C1302584
SLITLAMP EXAMINATION (DAY 7)
Beschrijving

SLITLAMP EXAMINATION (DAY 7)

Have any new or worsened abnormalities been identified since the last slitlamp exam?
Beschrijving

ANY_CHANGE [ANYCHG]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C1704258
Date of Exam:
Beschrijving

EXAM_DT [EXMDT]

Datatype

date

Maateenheden
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Aqueous Cell Right Eye
Beschrijving

SLIT_LAMP_AQ_CELL [SLAQC]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0003662
UMLS CUI [1,4]
C0229089
Aqueous Flare Right Eye
Beschrijving

SLIT_LAMP_AQ_FLARE [SLAQF]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0524490
UMLS CUI [1,4]
C0229089
Vitreous Cell Right Eye
Beschrijving

SLIT_LAMP_VIT_CELL [SLVITC]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0042905
UMLS CUI [1,4]
C0229089
Vitreous Hemorrhage Right Eye
Beschrijving

SLIT_LAMP_VIT_HEM [SLHEM]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0042909
UMLS CUI [1,4]
C0229089
Cataracts Subcapsular Right Eye
Beschrijving

SLIT_LAMP_CATA_SUB [SLCAS]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0235259
UMLS CUI [1,4]
C0229089
Cataracts Cortical Right Eye
Beschrijving

SLIT_LAMP_CATA_CORT [SLCAC]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0271160
UMLS CUI [1,4]
C0229089
Cataracts Nuclear Right Eye
Beschrijving

SLIT_LAMP_CATA_NUC [SLCAN]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0392557
UMLS CUI [1,4]
C0229089
Is artificial intraocular lens implant present? Right Eye
Beschrijving

LENS_RESULT [LNSRES2]

Datatype

boolean

Alias
UMLS CUI [1,1]
C0336564
UMLS CUI [1,2]
C0229089
Aqueous Cell Left Eye
Beschrijving

SLIT_LAMP_AQ_CELL [SLAQC]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0003662
UMLS CUI [1,4]
C0229090
Aqueous Flare Left Eye
Beschrijving

SLIT_LAMP_AQ_FLARE [SLAQF]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0524490
UMLS CUI [1,4]
C0229090
Vitreous Cell Left Eye
Beschrijving

SLIT_LAMP_VIT_CELL [SLVITC]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0042905
UMLS CUI [1,4]
C0229090
Vitreous Hemorrhage Left Eye
Beschrijving

SLIT_LAMP_VIT_HEM [SLHEM]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0042909
UMLS CUI [1,4]
C0229090
Cataracts Subcapsular Left Eye
Beschrijving

SLIT_LAMP_CATA_SUB [SLCAS]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0235259
UMLS CUI [1,4]
C0229090
Cataracts Cortical Left Eye
Beschrijving

SLIT_LAMP_CATA_CORT [SLCAC]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0271160
UMLS CUI [1,4]
C0229090
Cataracts Nuclear Left Eye
Beschrijving

SLIT_LAMP_CATA_NUC [SLCAN]

Datatype

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0392557
UMLS CUI [1,4]
C0229090
Is artificial intraocular lens implant present? Left Eye
Beschrijving

LENS_RESULT [LNSRES2]

Datatype

boolean

Alias
UMLS CUI [1,1]
C0336564
UMLS CUI [1,2]
C0229090
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Similar models

SLITLAMP EXAMINATION (DAY 7) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
SLITLAMP EXAMINATION (DAY 7)
Item
Have any new or worsened abnormalities been identified since the last slitlamp exam?
integer
C0419360 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
ANY_CHANGE [ANYCHG]
Code List
Have any new or worsened abnormalities been identified since the last slitlamp exam?
CL Item
Yes  (1)
CL Item
No  (2)
CL Item
Slitlamp Exam Not Done (3)
EXAM_DT [EXMDT]
Item
Date of Exam:
date
C0419360 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Aqueous Cell Right Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0003662 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
SLIT_LAMP_AQ_CELL [SLAQC]
Code List
Aqueous Cell Right Eye
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)
Item
Aqueous Flare Right Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0524490 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
LINE_NUMBER [LN2]
Code List
Aqueous Flare Right Eye
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
Vitreous Cell Right Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0042905 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
SLIT_LAMP_AQ_CELL [SLAQC]
Code List
Vitreous Cell Right Eye
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)
Item
Vitreous Hemorrhage Right Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0042909 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
SLIT_LAMP_AQ_CELL [SLAQC]
Code List
Vitreous Hemorrhage Right Eye
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)
Item
Cataracts Subcapsular Right Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0235259 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
SLIT_LAMP_AQ_CELL [SLAQC]
Code List
Cataracts Subcapsular Right Eye
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)
Item
Cataracts Cortical Right Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0271160 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
LINE_NUMBER [LN2]
Code List
Cataracts Cortical Right Eye
CL Item
1 - No difficulty at all (1)
CL Item
2 - A little difficulty (2)
CL Item
3 - Moderate difficulty (3)
CL Item
4 - Extreme difficulty (4)
CL Item
5 - Stopped doing this because of your eyesight (5)
CL Item
6 - Stopped doing this for other reasons or not interested in doing this (6)
Item
Cataracts Nuclear Right Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0392557 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
SLIT_LAMP_AQ_CELL [SLAQC]
Code List
Cataracts Nuclear Right Eye
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)
LENS_RESULT [LNSRES2]
Item
Is artificial intraocular lens implant present? Right Eye
boolean
C0336564 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Item
Aqueous Cell Left Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0003662 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
SLIT_LAMP_AQ_CELL [SLAQC]
Code List
Aqueous Cell Left Eye
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)
Item
Aqueous Flare Left Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0524490 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
SLIT_LAMP_AQ_CELL [SLAQC]
Code List
Aqueous Flare Left Eye
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)
Item
Vitreous Cell Left Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0042905 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
SLIT_LAMP_AQ_CELL [SLAQC]
Code List
Vitreous Cell Left Eye
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)
Item
Vitreous Hemorrhage Left Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0042909 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
SLIT_LAMP_AQ_CELL [SLAQC]
Code List
Vitreous Hemorrhage Left Eye
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)
Item
Cataracts Subcapsular Left Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0235259 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
SLIT_LAMP_AQ_CELL [SLAQC]
Code List
Cataracts Subcapsular Left Eye
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)
Item
Cataracts Cortical Left Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0271160 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
SLIT_LAMP_AQ_CELL [SLAQC]
Code List
Cataracts Cortical Left Eye
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)
Item
Cataracts Nuclear Left Eye
integer
C0419360 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0392557 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
SLIT_LAMP_AQ_CELL [SLAQC]
Code List
Cataracts Nuclear Left Eye
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)
LENS_RESULT [LNSRES2]
Item
Is artificial intraocular lens implant present? Left Eye
boolean
C0336564 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
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