ID

22620

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 (2)
  1. 6/8/17 6/8/17 -
  2. 6/11/17 6/11/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

June 8, 2017

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License

Creative Commons BY-NC 3.0
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SLITLAMP EXAMINATION (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

English

SLITLAMP EXAMINATION (DAY 0) 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
SLITLAMP EXAMINATION (DAY 0)
Description

SLITLAMP EXAMINATION (DAY 0)

Date of Exam:
Description

EXAM_DT [EXMDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Aqueous Cell
Description

SLIT_LAMP_AQ_CELL [SLAQC]

Data type

integer

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

SLIT_LAMP_AQ_FLARE [SLAQF]

Data type

integer

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

SLIT_LAMP_VIT_CELL [SLVITC]

Data type

integer

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

SLIT_LAMP_VIT_HEM [SLHEM]

Data type

integer

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

SLIT_LAMP_CATA_SUB [SLCAS]

Data type

integer

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

SLIT_LAMP_CATA_CORT [SLCAC]

Data type

integer

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

SLIT_LAMP_CATA_NUC [SLCAN]

Data type

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?
Description

LENS_RESULT [LNSRES2]

Data type

boolean

Alias
UMLS CUI [1,1]
C0336564
UMLS CUI [1,2]
C0229089
Aqueous Cell
Description

SLIT_LAMP_AQ_CELL [SLAQC]

Data type

integer

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

SLIT_LAMP_AQ_FLARE [SLAQF]

Data type

integer

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

SLIT_LAMP_VIT_CELL [SLVITC]

Data type

integer

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

SLIT_LAMP_VIT_HEM [SLHEM]

Data type

integer

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

SLIT_LAMP_CATA_SUB [SLCAS]

Data type

integer

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

SLIT_LAMP_CATA_CORT [SLCAC]

Data type

integer

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

SLIT_LAMP_CATA_NUC [SLCAN]

Data type

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?
Description

LENS_RESULT [LNSRES2]

Data type

boolean

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

SLITLAMP EXAMINATION (DAY 0) 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
SLITLAMP EXAMINATION (DAY 0)
EXAM_DT [EXMDT]
Item
Date of Exam:
date
C0419360 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Aqueous Cell
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
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
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
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
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
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
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
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
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
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
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
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
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
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?
boolean
C0336564 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Item
Aqueous Cell
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
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
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
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
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
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
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
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
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
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
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
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
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
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?
boolean
C0336564 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
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